Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS

Ethicon, Inc.161 enrolled

Overview

This single-arm, prospective, observational multicenter study will collect clinical data in a post-market setting across two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure). Investigators will perform the procedure using SFX Spiral PDS Plus in compliance with their standard surgical approach and the IFU.

Study Type

OBSERVATIONAL

Enrollment

161

Conditions

Bariatric - Sleeve Gastrectomy Staple Line Reinforcement Gynecology - Vaginal Cuff Closure

Interventions

Robotic Suturing of gastric sleeve oversew and vaginal cuff closureDEVICE

1. Robotic Bariatric Sleeve gastrectomy 2. Robotic Hysterectomy with or without oophorectomy;

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion: 1. Elect to have a Robotic Bariatric Sleeve Gastrectomy or Robotic Total Hysterectomy where STRATAFIX™ Spiral PDS™ Plus device is used for staple line re-enforcement or vaginal cuff closure, respectively 2. Are willing and able to give consent and comply with all study-related evaluations and treatment scheduled 3. Subjects are ≥ 18 years of age Exclusion: 1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product 3. Enrolled in a concurrent clinical study (drug/device) that might affect current study primary or secondary endpoints 4. Allergic to poly (p-dioxanon), IRGACARE®\* MP (triclosan) or D\&C Violet No. 2 colorant 5. Pregnant or lactating female subjects as confirmed prior to the procedure 6. Subjects undergoing radical hysterectomy (Type B, C and D) according to Querleu \& Morrow classification or gastric sleeve revision surgery

Locations (8)

Baptist Health South Florida

Miami, Florida, United States

Albany Medical

Albany, New York, United States

Mt. Sinai

New York, New York, United States

Lenox Hill hospital

New York, New York, United States

Outcomes

Primary Outcomes

Percentage of subjects with no bleeding or mild bleeding (defined as success) at the completion of the suturing at the organ layer (vaginal cuff closure or gastric staple line reinforcement using STRATAFIX™ Spiral PDS™ Plus).

The bleeding grade assessment used for the primary endpoint will be made right after the suturing is completed. Any re-bleeding after the initial assessment (just before the removal of the optics and trocars) from the suture line after this assessment will be considered a failure for the primary performance endpoint.

Time frame: Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)

Secondary Outcomes

Qualitative Assessment of Suture Handling

Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5

Time frame: Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)

Time to Closure (in minutes/seconds)

The time to closure is defined as time in minutes and seconds between placement of the first suture throw in the target tissue to the completion of closure of that layer. The time in minutes and seconds will be captured as per operating room procedure.

Time frame: Intra-op (during suturing of the target tissue, Day of surgery)

Overall procedure time (first incision to skin closure)

Overall time is calculated as first incision to skin closure

Time frame: Intra-op (during the surgery, Day of surgery)

Length of stay in hours

Time from admission to discharge

Time frame: Post-Operative up to 48 hrs

Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion

Data from ClinicalTrials.gov

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