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Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03310658
Study type Interventional
Source ZSX Medical LLC
Status Completed
Phase N/A
Start date April 17, 2017
Completion date May 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT02293369 - Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy N/A
Recruiting NCT01289314 - Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy N/A