NCT05570916

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: ZSX Medical LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.

Conditions

• Laparoscopic Hysterectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-17
• Primary completion: 2024-06-12
• Completion: 2025-05-10
• First posted: 2022-10-07
• Last updated: 2024-11-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study