Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch™ Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group (V-LOC barbed suture).

Study Overview

• Status: Terminated
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Device: Zip-stitch(TM)

Detailed Description

This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center

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:

1. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (may include TLH, LAVH, robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of HIV
2. History of Hepatitis C
3. History of diabetes, that in the opinion of the investigator may delay healing
4. Current use of systemic corticosteroids
5. Active infection of genitals, vagina, cervix, uterus or urinary tract
6. Active bacteremia, sepsis or other active systemic infection
7. Presence of Sexually Transmitted Infection (STI)
8. Evidence of pelvic inflammatory disease (PID)
9. Known clotting defects or bleeding disorders
10. Hemoglobin < 8 g/dL
11. Metastatic disease
12. On anticoagulant therapy
13. Participation in another interventional trial
14. Pregnancy
15. Abnormal PAP results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing
16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
17. Intra-op: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure

16. Intra-op: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 17. Intra-op: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 18. Intra-op: Cases requiring conversion to laparotomy prior to study intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Article - Zip-stitch Clips; Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy	Device: Zip-stitch(TM); The assigned intervention is used to close the cuff following colpotomy.
Other: Reference Group - V-Loc Barbed Suture; Will not be comparative against the test article, but will be performed for reference and safety.	Device: Zip-stitch(TM); The assigned intervention is used to close the cuff following colpotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint - Number of Participants With Implant Passing	Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks	Six-weeks post-operative
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence	Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.	Six-weeks post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Vaginal Cuff Closure	Binary, visual surgeon cuff closure evaluation	Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Number of Participants With Vaginal Cuff Healing	Binary, visual surgeon cuff healing evaluation	Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Comparison of Number of Participants With Implant Passing - Test to Reference	Percentage of subjects experiencing implant passing will be compared between test and reference groups	evaluated at six months post-operative
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety	Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups.	Evaluated after one week, six week, six month, and twelve month follow-up
Comparison of Incidence of Adverse Events - Test to Reference	Adverse events and serious adverse events will be tabulated for both the test and reference groups.	Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
Number of Participants With Non-increase in Dyspareunia at Follow-up	Non-increase in reported individual subject dyspareunia from baseline to follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.	Six-months post-operative and again at 12 months post-operative
Number of Participants With Non-increase in Pain at Follow-up	Non-increase in reported individual subject pain from baseline to follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.	Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase

Collaborators and Investigators

• Sponsor: ZSX Medical LLC
• Investigators: Principal Investigator: David O Holtz, M.D., Main Line Health

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: QD-PRO-045 Rev002

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.: No