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

Completed

• Conditions: Bariatric - Sleeve Gastrectomy Staple Line Reinforcement; Gynecology - Vaginal Cuff Closure
• Interventions: Device: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure

• Registration Number: NCT03937011
• Lead Sponsor: Ethicon, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Study Start: 2019-12-13
• Primary Completion: 2023-05-10
• Study Completion: 2023-11-13
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stratafix Arm	Robotic Suturing of gastric sleeve oversew and vaginal cuff closure	The single study arm would comprise of two different specialties in Robotic surgical procedures: Bariatric Sleeve gastrectomy (Staple line reinforcement) and Hysterectomy (Vaginal cuff closure).

Primary Outcome Measures

Name	Time	Method
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).	Intra-op assessment (During Surgery; after suturing of the target tissue, Day of surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Qualitative Assessment of Suture Handling	Intra-op (at surgery, after suturing of the target tissue layer, Day of surgery)	Suture breakage, correction suture used, reinforcement suture used, needle penetration, size, attachment; all rated 1-5
Time to Closure (in minutes/seconds)	Intra-op (during suturing of the target tissue, Day of surgery)	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.
Overall procedure time (first incision to skin closure)	Intra-op (during the surgery, Day of surgery)	Overall time is calculated as first incision to skin closure
Estimated intra-operative blood loss per institutional standard of care and incidence of subjects requiring blood transfusion	Intra-Op (during the surgery, Day of surgery)	Blood loss calculated as per the standard of care of each institution
Abnormal vaginal discharge (total hysterectomy subjects)	14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)	Hysterectomy patients will be assessed for any abnormal vaginal discharge if any.
C-SATS GEARS score	Intra-op (during the surgery, Day of surgery)	Global Evaluative Assessment of Robotic Skills (GEARS). Its a validated assessment tool for grading overall technical proficiency for robotic surgery. GEARS measures manual dexterity and fluidity of motion and does not define surgical or clinical judgement. The scales are Depth perception, Bimanual dexterity, efficiency, force sensitivity and robotic control.Each scale is scored 1 - 5, which means the total score could range from 5 - 25.
Length of stay in hours	Post-Operative up to 48 hrs	Time from admission to discharge
Incisional site physical assessment:is suture palpable, suture line intact, or tender (all rated yes/no)	14 days post-perative 90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)	Incisional site will be assessed for hysterectomy subjects to see if the suture is palpable suture, tender or intact at the target site
Intra-operative leak test in bariatric procedure as per institutional standard of care, if any	Intra-op (during Surgery; Day of surgery)	Leak test for sleeve gastrectomy patient as per institution standard
Post-operative male/female dyspareunia related to sutures (total hysterectomy subjects)	90 days post-operative (+/- 30 days), 180 days post-operative (+/- 30 days)	Dyspareunia here is defined as painful sexual intercourse due to the sutures

Trial Locations

Locations (8)

Albany Medical; 🇺🇸 Albany, New York, United States

Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie; 🇩🇪 Kiel, Germany

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States

Universitaetsklinikum Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Mt. Sinai; 🇺🇸 New York, New York, United States

Lenox Hill hospital; 🇺🇸 New York, New York, United States

University of Naples; 🇮🇹 Naples, Italy

University Pisa; 🇮🇹 Pisa, Italy