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

NCT05570916 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Laparoscopic Hysterectomy

Interventions

DEVICE

Zip-stitch(R)

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

DEVICE

Reference suture

Standard suture for vaginal cuff closure during laparoscopic hysterectomy

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • ZSX Medical LLC

    lead INDUSTRY

Principal Investigators

  • David Holtz, MD · Main Line Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2024-06-12
Completion
2025-05-10
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 NCT05570916 on ClinicalTrials.gov