NCT04081727

Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

Terminated NA Results posted Last updated 7 September 2022

What this trial tests

NA trial testing Zip-stitch(TM) in Laparoscopic Hysterectomy in 2 participants. Terminated before completion.

Timeline

6 November 2019

Primary endpoint
31 August 2020

22 June 2021

Quick facts

Lead sponsor	ZSX Medical LLC
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	2
Start date	6 November 2019
Primary completion	31 August 2020
Estimated completion	22 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Zip-stitch(TM)

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.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Efficacy Endpoint - Number of Participants With Implant Passing Primary · Six-weeks post-operative

Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks

Group	Value	95% CI
Test Article - Zip-stitch Clips	0
Reference Group - VICRYL Suture	1

Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence Primary · Six-weeks post-operative

Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.

Group	Value	95% CI
Test Article - Zip-stitch Clips	0
Reference Group - Vicryl Suture	0

Number of Participants With Successful Vaginal Cuff Closure Secondary · Performed at one week, six weeks, and six months after surgery; reported here at six weeks

Binary, visual surgeon cuff closure evaluation

Group	Value	95% CI
Test Article - Zip-stitch Clips	1
Reference Group - Vicryl Suture	0

Number of Participants With Vaginal Cuff Healing Secondary · Performed at one week, six weeks, and six months after surgery; reported here at six weeks

Binary, visual surgeon cuff healing evaluation

Group	Value	95% CI
Test Article - Zip-stitch Clips	1
Reference Group - Vicryl Suture	0

Comparison of Number of Participants With Implant Passing - Test to Reference Secondary · evaluated at six months post-operative

Percentage of subjects experiencing implant passing will be compared between test and reference groups

Group	Value	95% CI
Test Article - Zip-stitch Clips	1
Reference Group - Vicryl Suture	1

Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety Secondary · Evaluated after one week, six week, six month, and twelve month follow-up

Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.

Group	Value	95% CI
Test Article - Zip-stitch Clips	0
Reference Group - Vicryl Suture	0

Comparison of Incidence of Adverse Events - Test to Reference Secondary · Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time

Adverse events and serious adverse events will be tabulated for both the test and reference groups.

Group	Value	95% CI
Test Article - Zip-stitch Clips	1
Reference Group - Vicryl Suture	0

Number of Participants With Non-increase in Dyspareunia at Follow-up Secondary · Six-months post-operative and again at 12 months post-operative

Non-increase in reported individual subject dyspareunia from baseline to follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.

Group	Value	95% CI
Test Article - Zip-stitch Clips	0
Reference Group - Vicryl Suture	0

Number of Participants With Non-increase in Pain at Follow-up Secondary · Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase

Non-increase in reported individual subject pain from baseline to follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.

Group	Value	95% CI
Test Article - Zip-stitch Clips	1
Reference Group - Vicryl Suture	1

Adverse events — posted to ClinicalTrials.gov

Time frame: One year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Test Article - Zip-stitch Clips

Serious: 0/1 (0%)

Deaths: 0/1

Reference Group - Vicryl Suture

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Test Article - Zip-stitch …	Reference Group - Vicryl S…
Cuff cellulitis	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT04081727 adverse events section.

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 (V-LOC barbed suture).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.