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

Completed

Conditions studied: Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure

In brief

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.

Key facts

Study ID

NCT03937011

Run by

Ethicon, Inc.

People needed

161

Starts

2019-12-11

Expected to finish

2023-11-13

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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
• Universitaetsklinikum Hamburg Eppendorf — Hamburg, Germany
• Klinuk fur Allgemelne, Viszeral-ThoraxTransplantations- und Kinderchirurgie — Kiel, Germany
• University of Naples — Naples, Italy
• University Pisa — Pisa, Italy

Full record on ClinicalTrials.gov

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