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

NCT04081727 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-09-07

Study results available
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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 (V-LOC barbed suture).

Conditions

  • Laparoscopic Hysterectomy

Interventions

DEVICE

Zip-stitch(TM)

The assigned intervention is used to close the cuff following colpotomy.

Sponsors & Collaborators

  • ZSX Medical LLC

    lead INDUSTRY

Principal Investigators

  • David O Holtz, M.D. · Main Line Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2020-08-31
Completion
2021-06-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081727 on ClinicalTrials.gov