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Suture

Zip-stitch(TM) for Laparoscopic Hysterectomy

N/A
Waitlist Available
Led By David O Holtz, M.D.
Research Sponsored by ZSX Medical LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (may include TLH, LAVH, robotic assisted vaginal hysterectomy)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated at six months post-operative
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new vaginal closure system to a standard one. The primary outcome is the rate of implant passing, with secondary outcomes including safety and effectiveness endpoints.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
This trial's timeline: 3 weeks for screening, Varies for treatment, and six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint - Number of Participants With Implant Passing
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
Secondary outcome measures
Comparison of Incidence of Adverse Events - Test to Reference
Comparison of Number of Participants With Implant Passing - Test to Reference
Number of Participants With Non-increase in Dyspareunia at Follow-up
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Test Article - Zip-stitch ClipsExperimental Treatment1 Intervention
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Group II: Reference Group - V-Loc Barbed SutureExperimental Treatment1 Intervention
Will not be comparative against the test article, but will be performed for reference and safety.

Find a Location

Who is running the clinical trial?

ZSX Medical LLCLead Sponsor
2 Previous Clinical Trials
69 Total Patients Enrolled
1 Trials studying Laparoscopic Hysterectomy
59 Patients Enrolled for Laparoscopic Hysterectomy
David O Holtz, M.D.Principal InvestigatorMain Line Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
2019. "Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04081727.
~0 spots leftby Apr 2025
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