A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

Ethicon Endo-Surgery265 enrolled

Overview

This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and thoracic surgical procedures). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the HARMONIC 1100 Shears and Generator G11 instructions for use.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

265

Conditions

Pediatric Procedures Adult Hepato-pancreato-biliary (HPB) Procedures Adult Lower Gastrointestinal Procedures Adult Gastric Procedures Adult Gynecological Procedures

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Pediatric population: 1. Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU; 2. Less than 18 years of age at the time of procedure; and 3. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the study and provide written informed consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study. Adult population: 1. Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 1100 Shears per the IFU; 2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and 3. At least 18 years of age. Exclusion Criteria: Preoperative 1. Physical or psychological condition which would impair study participation; 2. Female subjects, of childbearing age, who are pregnant; or 3. Enrollment in a concurrent interventional clinical study that could impact the study endpoints. Intraoperative 1\. The HARMONIC 1100 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure.

Locations (7)

Baptist Health

Jacksonville, Florida, United States

Indiana University

Indianapolis, Indiana, United States

IU Health University Hospital

Indianapolis, Indiana, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Centre Hospitalier de l'Universite de Montreal

Montreal, Canada

Toronto General Hospital

Toronto, Canada

Western General Hospital

Edinburgh, Scotland, United Kingdom

Outcomes

Primary Outcomes

Number of Vessels Transected With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

Number of vessels transected with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: On the day of transection (Day 0)

Number of Participants With Device-related Adverse Events (AEs)

Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study device. Possible refers to the relationship with the use of the device is weak but cannot be ruled out completely; Probable refers to the relationship with the use of the device seems relevant and/or the event cannot reasonably be explained by another cause, but additional information may be obtained; Causal relationship refers to the event is associated with the device or with procedures beyond reasonable doubt.

Time frame: From Day 0 up to post-procedure follow up visit (up to 28 days)

Secondary Outcomes

Number of Vessels Transections With Diameter >5 to 7 mm With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

Number of vessels transected with diameter \>5 to 7 mm with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: On the day of transection (Day 0)

Number of Participants Using HARMONIC 1100 Shears For Sealing and Transection of Lymphatic Vessels as Assessed by Surgeon Satisfaction Scale Score

Number of participants using HARMONIC 1100 Shears for sealing and transection of lymphatic vessels as assessed by Surgeon Satisfaction Scale Score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for sealing and transection of lymphatic vessel by HARMONIC 1100 Shears.

Time frame: On the day of transection (Day 0)

Number of Vessels Transected With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale

Number of vessels transected with hemostasis (Grade 1 to 4) based on hemostasis grading scale was reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

Time frame: On the day of transection (Day 0)

Number of Grade 4 Vessel Transections Requiring Hemostasis Measures

Number of Grade 4 vessel transections requiring hemostasis measures such as hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products and other products were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with HARMONIC 1100 Shears; or Grade 4: significant bleeding (pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (hemoclips, staples, sutures, fibrin sealants, adjunctive topical hemostats (except fibrin sealants), other advanced energy products). Since multiple responses were collected, sum of the data of each category exceeds the overall number of units analyzed.

Time frame: On the day of transection (Day 0)

A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes