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NCT03937011
Post-Market Clinical Follow-Up of STRATAFIX™ Spiral PDS™ PLUS
trial testing Robotic Suturing of gastric sleeve oversew and vaginal cuff closure in Bariatric - Sleeve Gastrectomy Staple Line Reinforcement in 161 participants. Completed in 13 November 2023.
10 May 2023
Quick facts
| Lead sponsor | Ethicon, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 161 |
| Start date | 11 December 2019 |
| Primary completion | 10 May 2023 |
| Estimated completion | 13 November 2023 |
| Sites | 8 locations across Italy, United States, Germany |
Drugs / interventions tested
- Robotic Suturing of gastric sleeve oversew and vaginal cuff closure
Conditions studied
- Bariatric - Sleeve Gastrectomy Staple Line Reinforcement — all drugs for Bariatric - Sleeve Gastrectomy Staple Line Reinforcement →
- Gynecology - Vaginal Cuff Closure — all drugs for Gynecology - Vaginal Cuff Closure →
Sponsor
Ethicon, Inc. — full company profile →
Who can join
18 and older, any sex, with Bariatric - Sleeve Gastrectomy Staple Line Reinforcement or Gynecology - Vaginal Cuff Closure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03937011
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Ethicon, Inc. trials
Trials by the same sponsor.
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- NCT05299606 — POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy) · NA · terminated
- NCT04829175 — Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry · recruiting
- NCT04889989 — Microwave Ablation in Chinese Patients With Lung Tumors · NA · terminated
- NCT04829058 — GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03937011 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ethicon, Inc.
- Last refreshed: 17 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03937011.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing