A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures

  • End date
    May 30, 2023
  • participants needed
  • sponsor
    Ethicon, Inc.
Updated on 23 October 2022


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.

Condition Bariatric - Sleeve Gastrectomy Staple Line Reinforcement, Gynecology - Vaginal Cuff Closure
Treatment Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
Clinical Study IdentifierNCT03937011
SponsorEthicon, Inc.
Last Modified on23 October 2022


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