Trials / Completed
CompletedNCT03937011
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
A Prospective, Multicenter, Multispecialty Evaluation of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices in Robotic Procedures
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 161 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Robotic Suturing of gastric sleeve oversew and vaginal cuff closure | 1. Robotic Bariatric Sleeve gastrectomy 2. Robotic Hysterectomy with or without oophorectomy; |
Timeline
- Start date
- 2019-12-11
- Primary completion
- 2023-05-10
- Completion
- 2023-11-13
- First posted
- 2019-05-03
- Last updated
- 2026-02-17
Locations
8 sites across 3 countries: United States, Germany, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03937011. Inclusion in this directory is not an endorsement.