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

Not Applicable

Completed

• Conditions: Total Laparoscopic Hysterectomy
• Interventions: Device: Zip-Stitch Soft Tissue Closure System

• Registration Number: NCT03310658
• Lead Sponsor: ZSX Medical LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-17
• Primary Completion: 2017-06-30
• Study First Submitted: 2017-09-26
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Completion: 2018-05-30
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Provision of signed and dated Informed Consent Form
• Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
• Female, age 18 years or older
• Indicated for Total Laparoscopic Hysterectomy

Exclusion Criteria

• HIV
• Hepatitis C
• Diabetics
• Use of systemic corticosteroids
• History of pelvic irradiation
• Active infection
• History of bleeding problems/hemophilia
• Cancer
• Cases in which vaginal cuff closure is intended to be performed robotically
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Study Site: UANL	Zip-Stitch Soft Tissue Closure System	As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy.

Primary Outcome Measures

Name	Time	Method
Device Ease of Use	Immediately following procedure	Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.

Secondary Outcome Measures

Name	Time	Method
Vaginal Cuff Closure Time	During Procedure.	Procedural time from uterine excision to successful vaginal cuff closure.
Total Surgical Time	During Procedure.	Total procedural time.
Vaginal Cuff Closure	During procedure.	Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.
Device Use Learning Curve assessed with a Surgeon Survey	Assessed immediately following study completion during surgeon survey.	Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.
Sexual Discomfort	Assessed at 1 and 6 week follow-up visits.	Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).

Trial Locations

Locations (1)

Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey; 🇲🇽 Monterrey, Nuevo León, Mexico