NCT03310658

Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy

Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ZSX Medical LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device. Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.

Conditions

• Total Laparoscopic Hysterectomy

Interventions

Type	Name	Description
DEVICE	Zip-Stitch Soft Tissue Closure System	The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.

Timeline

• Start date: 2017-04-17
• Primary completion: 2017-06-30
• Completion: 2018-05-30
• First posted: 2017-10-16
• Last updated: 2018-09-04

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated device study