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ACTIVE NOT RECRUITING
NCT05570916
NA

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

Sponsor: ZSX Medical LLC

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2023-08-17

Completion Date

2025-05-10

Last Updated

2024-11-18

Healthy Volunteers

Yes

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

Locations (5)

Northwestern University

Chicago, Illinois, United States

Unified Women's Clinical Research

Winston-Salem, North Carolina, United States

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Tidewater Clinical Research

Virginia Beach, Virginia, United States

Mon Health Medical Center

Morgantown, West Virginia, United States