VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial

N/ATerminatedNCT03820947

Medtronic Endovascular506 enrolled

Overview

Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

The study is designed with two randomized studies and one single arm study. Two randomized studies are for CEAP 2-5 subjects: 1. VenaSeal vs. Surgical Stripping Study (outside of the United States only) 2. VenaSeal vs. ETA Study The single arm study is for CEAP 6 subjects with active venous leg ulcers (VLU): 1\. VLU Study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

506

Conditions

Venous Reflux

Interventions

VenaSeal™ SystemDEVICE

The VenaSeal™ System is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.

Endothermal Ablation (ETA)DEVICE

ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein. Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.

Surgical StrippingPROCEDURE

Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient is ≥18 years of age 2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS) 3. Eligibility for treatment: * VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA * VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping * VLU Study: patients should be eligible for treatment with the VenaSeal™ system 4. Treatable refluxing segment of target vein(s) 10 cm in length or longer 5. Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing 6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times 7. Patient has an ability to understand the requirements of the study and to provide informed consent Exclusion Criteria: 1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity 2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care 3. Patient has abnormal pulse exam or ABI \<0.8 4. Patient has acute superficial thrombophlebitis 5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure 6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year) 7. IFU contraindications: * VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s) * VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s) * VLU Study: Patient has VenaSeal™ system IFU contraindication(s) 8. Patient is non-ambulatory 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure 10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures 11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study 12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion. 13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory 14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

Locations (32)

Outcomes

Primary Outcomes

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - early (VenousTSQe). Total score ranges from 0-36, and a higher score means a higher peri-procedural venous treatment satisfaction.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Measured by a validated, patient-centered venous treatment satisfaction questionnaire - status (VenousTSQs). Total score ranges from 0-36, and a higher score means a higher venous treatment satisfaction.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Surgical Stripping: Primary Endpoint: Patient Satisfaction as Measured by a Validated, Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Primary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Each Target Vein at the Time of Index Procedure.

Data from ClinicalTrials.gov

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Yavapai Regional Medical Center

Prescott Valley, Arizona, United States

PIMA Heart and Vascular

Tucson, Arizona, United States

Valley Vascular Surgical Associates

Fresno, California, United States

Vascular Care Connecticut

Darien, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Vascular Care Group

Wellesley, Massachusetts, United States

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

...and 22 more locations

Secondary Outcomes

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system and ETA procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Time frame: 6 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Time frame: 6 months

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Anatomic Closure of the Primary Target Superficial Truncal Vein at 6 Months.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 6 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 6 months.

Time frame: 6 months

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Time to return to work reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to work through 30 days.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Surgical Stripping: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Time frame: 30 days

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Key Secondary Endpoint: Time to Return to Work as Reported by the Patient.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system or ETA it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Time frame: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12 Months.

Anatomic closure of the primary target superficial truncal vein, defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Time frame: 30 days, 12 months

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Primary Target Vein at 30 Days, and 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system it is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of primary target veins with anatomic closure through 30 days and 12 months.

Time frame: 30 days and 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12 Months.

Anatomic closure of target superficial truncal vein defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual primary target vein after surgical stripping procedures. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Time frame: 30 days, 6, 12 months

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Anatomic Closure of Target Vein at 30 Days, and 6, 12, 24, 36, 48 and 60 Months.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm. Time to lack of anatomic closure was reported by using the Kaplan-Meier survival probability estimate at 30 days, 6 months, and 12 months, expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins with anatomic closure through 30 days, 6 months, and 12 months.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

For subjects treated with the VenaSeal™ system or ETA this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Time frame: Post Index procedure, on the day of the procedure immediately following treatment

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

Defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSeal™ system, or the absence of refluxing or residual vein after surgical stripping procedures.

Time frame: Post Index procedure, on the day of the procedure immediately following treatment

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Technical Success of Each Target Vein Immediately Post-index Procedure.

For subjects treated with the VenaSeal™ system this is defined as DUS showing vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.

Time frame: Post Index procedure, on the day of the procedure immediately following treatment

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months, Assessed at Each Follow-up Visit.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Reintervention of Any Target Vein (Including Primary Target Vein) Through 12 Months.

As measured by the time between the index procedure and the first reintervention procedure. Time to reintervention was reported by using the event free Kaplan-Meier survival probability estimate at 12 months expressed as a percentage. The data values below represent the Kaplan-Meier survival probability as a percentage of target veins without a reintervention through 12 months.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), Symptomatic deep vein thrombosis (DVT) events.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Time frame: 12 months

Single Arm Venous Leg Ulcer (VLU) Study: VenaSeal™ System: Secondary Endpoint: Adverse Events (AEs) Occurring in the Target Limb, Evaluated From Index Procedure Through 12 Months.

Hypersensitivity to VenaSeal™ adhesive, Phlebitis, Granuloma, Endovenous glue induced thrombosis (EGIT), Symptomatic deep vein thrombosis (DVT) events.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Additional Events Evaluated Through 12 Months.

Symptomatic pulmonary embolism (PE), Serious adverse events (SAEs).

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Time frame: 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Number and Type of Adjunctive Treatments Conducted Through 12 Months Post-index Procedure.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Healthcare Utilization Related to the Target Limb VRD.

Determined by the number of healthcare visits conducted, and other health-related resources utilized (e.g., home healthcare services) between study visits through 12 months.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Procedures, Tests and Treatment of AEs Related to the Treatment Modality or Index Procedure Through 12 Months.

Time frame: 12 months

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Time to return to normal activities reported by using the cumulative incidence probability estimate of the event happening at 30 days, expressed as a percentage. The data values below represent the cumulative incidence probability as the percentage of participants returning to normal activities through 30 days.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Time frame: 30 days

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Time to Return to Normal Activities as Reported by the Patients.

Time frame: 30 days

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Intra-procedural and Post-procedural Pain at the Index Procedure, and 7 Days and 30 Days.

Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.

Time frame: Intra-procedure, post-procedure (on the day of the procedure immediately following treatment), 7 days and 30 days

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Measured by the revised Venous Clinical Severity Score (rVCSS) and subject self-reporting. rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease. The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 7 and 30 days, and at 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12 Months Compared to Baseline.

Time frame: 7 and 30 days, and at 6 and 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in Venous Disease Symptoms at 7 and 30 Days, and at 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life. The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6 and 12 Months Compared to Baseline.

Time frame: 30 days, and 6 and 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in AVVQ Score at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6 and 12 Months Compared to Baseline.

EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6 and 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) at 30 Days, and 6, 12, 24, 36, 48 and 60 Months Compared to Baseline.

EQ-5D Index scale from \<0 to 1.0 (\<0 worse than dead, 0 is dead and 1.0 is full health). The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6 and 12 months

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6 and 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the 36-Item Short Form Health Survey (SF-36) Reported by the Patient at 30 Days, and 6 and 12 Months Compared to Baseline.

The total score ranges from 0 to 100, with higher scores indicating better general health perception. The outcome measure data reports changes compared to baseline at the different time frames.

Time frame: 30 days, and 6 and 12 months

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Subjects answer their general quality of life with potential responses on an ordinal scale: excellent, very good, good, neither good nor bad, bad, very bad, or extremely bad. Subjects also answer what their quality of life would be without varicose veins with potential responses on an ordinal scale: very much better, much better, a little better, the same, or worse. The outcome measure data reports the responses at the different time frames including baseline.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12 Months Compared to Baseline.

Time frame: 30 days, and 6, 12 months

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Change in the Venous Dependent Quality of Life (VenousDQoL) Reported by the Patient at 30 Days, and 6, 12, 24, 36, 48, and 60 Months Compared to Baseline.

Time frame: 30 days, and 6, 12 months. Data for additional time points 24, 36, 48 and 60 months will be added to additional outcome measure with next posting as data collection is still ongoing.

Randomized Study VenaSeal™ System Versus Endothermal Ablation (ETA): Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Time frame: Post-index procedure, on the day of the procedure immediately following treatment

Randomized Study VenaSeal™ System Versus Surgical Stripping: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Time frame: Post-index procedure, on the day of the procedure immediately following treatment

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Provider Experience Will be Assessed Post-index Procedure, Evaluating Overall Satisfaction With the Procedure.

Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).

Time frame: Post-index procedure, on the day of the procedure immediately following treatment

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Peri-procedural Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQe) at 30 Days.

Time frame: 30 days

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Patient Satisfaction as Measured by a Validated Patient-centered Venous Treatment Satisfaction Questionnaire (VenousTSQs) at 30 Days.

Time frame: 30 days

Single Arm Venous Leg Ulcer (VLU) Study: Secondary Endpoint: Elimination of Clinically Relevant Superficial Truncal Disease in Target Vein at the Time of Index Procedure as Measured by the Percentage of Target Veins Successfully Treated.

Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.

Time frame: Post-index procedure, on the day of the procedure immediately following treatment