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

NCT03937011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 161

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Robotic Suturing of gastric sleeve oversew and vaginal cuff closure

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

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2023-05-10
Completion
2023-11-13
FDA Device
Yes

Countries

  • United States
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937011 on ClinicalTrials.gov