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

NCT03310658 | Completed FDA Device

• 1 other identifier: ZHP01-1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Laparoscopic Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Device Ease of Use

  Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.

  Immediately following procedure

Secondary Outcomes (5)

• Vaginal Cuff Closure

  During procedure.

• Vaginal Cuff Closure Time

  During Procedure.

• Total Surgical Time

  During Procedure.

• Device Use Learning Curve assessed with a Surgeon Survey

  Assessed immediately following study completion during surgeon survey.

• Sexual Discomfort

  Assessed at 1 and 6 week follow-up visits.

Study Arms (1)

Single Study Site: UANL

EXPERIMENTAL

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.

Device: Zip-Stitch Soft Tissue Closure System

Interventions

Zip-Stitch Soft Tissue Closure System DEVICE

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.

Single Study Site: UANL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZSX Medical LLC: lead

Study Sites (1)

Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey

Monterrey, Nuevo León, 64460, Mexico

Location

Study Officials

• Dan Mazzucco, PhD

  ZSX Medical LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 16, 2017
• Study Start: April 17, 2017
• Primary Completion: June 30, 2017
• Study Completion: May 30, 2018
• Last Updated: September 4, 2018

Record last verified: 2017-10

Locations

ME (1)