NCT04081727

Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• 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 (V-LOC barbed suture).

Detailed description

This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.

Conditions

• Laparoscopic Hysterectomy

Interventions

Type	Name	Description
DEVICE	Zip-stitch(TM)	The assigned intervention is used to close the cuff following colpotomy.

Timeline

• Start date: 2019-11-06
• Primary completion: 2020-08-31
• Completion: 2021-06-22
• First posted: 2019-09-09
• Last updated: 2022-09-07
• Results posted: 2022-09-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study