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

Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study

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.

Study Overview

• Status: Completed
• Conditions: Total Laparoscopic Hysterectomy
• Intervention / Treatment: Device: Zip-Stitch Soft Tissue Closure System

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: ZSX Medical LLC
• Investigators: Study Director: Dan Mazzucco, PhD, ZSX Medical LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ZHP01-1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes