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NCT03310658
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
NA trial testing Zip-Stitch Soft Tissue Closure System in Total Laparoscopic Hysterectomy in 10 participants. Completed in 30 May 2018.
30 June 2017
Quick facts
| Lead sponsor | ZSX Medical LLC |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 17 April 2017 |
| Primary completion | 30 June 2017 |
| Estimated completion | 30 May 2018 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Zip-Stitch Soft Tissue Closure System
Conditions studied
- Total Laparoscopic Hysterectomy — all drugs for Total Laparoscopic Hysterectomy →
Sponsor
ZSX Medical LLC
Who can join
18 and older, female only, with Total Laparoscopic Hysterectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device. Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.
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 NCT03310658
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Total Laparoscopic Hysterectomy
Currently open trials in the same condition.
- NCT07362680 — Effects of Ultrasound-guided Recruitment Manoeuvres on Postoperative Pulmonary Complications in OSA Patients Undergoing · NA · recruiting
- NCT06867614 — Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy · NA · recruiting
Other ZSX Medical LLC trials
Trials by the same sponsor.
- NCT05570916 — Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy · NA · active not recruiting
- NCT04081727 — Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study · NA · terminated
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 NCT03310658 (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 ZSX Medical LLC
- Last refreshed: 4 September 2018
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/NCT03310658.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing