CompletedNot Applicable

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

United States23 participantsStarted 2023-08-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. History of Human Immunodeficiency Virus (HIV)
. History of Hepatitis C
. History of diabetes that, in the opinion of the investigator, may delay healing
. Current use of systemic corticosteroids
. Active infection of genitals, vagina, cervix, uterus or urinary tract
. Active bacteremia, sepsis or other active systemic infection
. Presence of Sexually Transmitted Infection (STI)
. Evidence of pelvic inflammatory disease (PID)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vaginal Cuff Dehiscence Rate

Timeframe: This will be evaluated through six-weeks post-operative.

Number of Participants With Implant Passing Through Six Weeks

Timeframe: This will be evaluated through six weeks post operative.

Trial details

NCT IDNCT05570916

SponsorZSX Medical LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-12

Results submitted2025-08-18

View on ClinicalTrials.gov More Laparoscopic Hysterectomy trials