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

ZSX Medical

Status: Completed

Conditions: Total Laparoscopic Hysterectomy

Treatments: Device: Zip-Stitch Soft Tissue Closure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03310658

ZHP01-1.0

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single Study Site: UANL

Experimental group

Description:

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.

Treatment:

Device: Zip-Stitch Soft Tissue Closure System