Finished
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
NCT03937011 · Ethicon, Inc. · Updated 17 Feb 2026
- What is being tested
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
- For
- Bariatric - Sleeve Gastrectomy Staple Line Reinforcement; Gynecology - Vaginal Cuff Closure
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 161 people. The full rules are on the registry page.
- Where
- United States, Germany, Italy (8 sites)
- When
- Starts or started 11 Dec 2019, ends 13 Nov 2023. Registered 3 May 2019.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Baptist Health South FloridaMiami, Florida, United States
- Albany MedicalAlbany, New York, United States
- Mt. SinaiNew York, New York, United States
- Lenox Hill hospitalNew York, New York, United States
- Universitaetsklinikum Hamburg EppendorfHamburg, Germany
- Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und KinderchirurgieKiel, Germany
- University of NaplesNaples, Italy
- University PisaPisa, Italy