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NCT03937011 · ClinicalTrials.gov registry record
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
A clinical trial, sponsored by Ethicon.
- Completed
- Registry status
- 161
- Enrollment target
NCT03937011: Completed study, sponsored by Ethicon.
NCT03937011 is a clinical trial that has completed, run by Ethicon. The registered enrollment target is 161 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03937011 has completed, sponsored by Ethicon.
- COMPLETED
- Registry status
- 161 participants
- Enrollment target
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.
Primary Outcome
The bleeding grade assessment used for the primary endpoint will be made right after the suturing is completed. Any re-bleeding after the initial assessment (just before the removal of the optics and trocars) from the suture line after this assessment will be considered a failure for the primary performance endpoint.
Interventions
- DEVICE Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2023-11-13 |
What the finished NCT03937011 record still lists
NCT03937011 is an observational study that tracks outcomes without assigning an intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Robotic Suturing of gastric sleeve oversew and vaginal cuff closure is the first listed.
NCT03937011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03937011 about?
NCT03937011 is a clinical study titled "Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS". 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 perf...
What is the current status of trial NCT03937011?
This trial is currently completed. The enrollment target is 161 participants. The study started on 2019-12-11. Estimated completion is 2023-11-13.
What interventions are being tested in trial NCT03937011?
The interventions under investigation include: Robotic Suturing of gastric sleeve oversew and vaginal cuff closure (DEVICE).
Who is sponsoring clinical trial NCT03937011?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
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