CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled / 23 target
Drug / intervention
Zip-stitch(R) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05570916
NCT05570916N/ACompletedMonitor (0.7/mo)Completion was 19mo ago
CompareCT.gov

Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

ZSX Medical LLC·interventional·Posted Oct 7, 2022·Updated Jun 12, 2026

In Brief

A clinical study evaluating Zip-stitch(R) and Reference suture for Laparoscopic Hysterectomy. Completed, enrolled 23 participants across 5 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLaparoscopic Hysterectomy
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
2023202420252026
First PostedOct 7, 2022
Enrollment StartAug 17, 2023
Primary CompletionNov 12, 2024
Study CompletionMay 10, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.7 years ago

Arms & Interventions

Test Article - Zip-stitch Clipsexperimental

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Device: Zip-stitch(R)
Reference Groupother

Will not be comparative against the test article, but will be performed for reference and safety.

Device: Reference suture

Interventions

Zip-stitch(R)device

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Reference suturedevice

Standard suture for vaginal cuff closure during laparoscopic hysterectomy