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

NCT ID: NCT03310658

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2018-05-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single Study Site: UANL

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.

Group Type: EXPERIMENTAL

Zip-Stitch Soft Tissue Closure System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ZSX Medical LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Mazzucco, PhD

Role: STUDY_DIRECTOR

ZSX Medical LLC

Locations

Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

ZHP01-1.0

Identifier Type: -

Identifier Source: org_study_id