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NCT05570916: ZIMS
Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
NA trial testing Zip-stitch(R) in Laparoscopic Hysterectomy in 59 participants. Participants enrolled and being followed up; not accepting new ones.
12 June 2024
Quick facts
| Lead sponsor | ZSX Medical LLC |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 59 |
| Start date | 17 August 2023 |
| Primary completion | 12 June 2024 |
| Estimated completion | 10 May 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Zip-stitch(R)
- Reference suture
Conditions studied
- Laparoscopic Hysterectomy — all drugs for Laparoscopic Hysterectomy →
Sponsor
ZSX Medical LLC
Who can join
18 and older, female only, with Laparoscopic Hysterectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05570916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other ZSX Medical LLC trials
Trials by the same sponsor.
- NCT04081727 — Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study · NA · terminated
- NCT03310658 — Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy · NA · completed
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 NCT05570916 (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: 18 November 2024
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/NCT05570916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing