Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy (ZIMS)

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Device: Zip-stitch(R); Device: Reference suture

Detailed Description

This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive 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 and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Hospital
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Tidewater Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Mon Health Medical Center

Participation Criteria

Eligibility Criteria

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

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 (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy)

Exclusion Criteria:

1. History of Human Immunodeficiency Virus (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 Papanicolaou test (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-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
20. Intra-operative: 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: Quadruple

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(R); Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Other: Reference Group; Will not be comparative against the test article, but will be performed for reference and safety.	Device: Reference suture; Standard suture for vaginal cuff closure during laparoscopic hysterectomy; Other Names: V-Loc or VICRYL sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Cuff Dehiscence Rate	Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. Vaginal cuff dehiscence is defined as rupture of the surgical wound requiring surgical re-intervention.	This will be evaluated through six-weeks post-operative.
Number of Participants With Implant Passing Through Six Weeks	Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure. This endpoint is based upon the rate of spontaneous implant passing events. A single event may be pieces of one or more clips or sutures being spontaneously passed by the patient (i.e., not removed by medical staff). For the primary endpoint, only passing of clips will be counted, but for secondary endpoint, clips or sutures will be counted. When implant passing was reported, subjects were asked to collect and provide passed implants, and an in-person evaluation was performed. This involved a visual cuff closure and healing assessment.	This will be evaluated through six weeks post operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 weeks and 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 through six-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 through six-month follow-up
Number of Participants With Successful Vaginal Cuff Closure	Cuff closure was assessed by a qualified independent blinded evaluator at zero, one, and six weeks, as well as at six months, according to a standardized protocol. Surgeon visual assessment graded vaginal cuffs as closed (Y) or not closed (N).	Performed intra-operatively and at one week, six weeks, and six months after surgery
Number of Participants With Healed Vaginal Cuffs	Vaginal cuff healing was visually assessed by a blinded evaluator at one week, six weeks, and six months. Evaluator visual assessment graded vaginal cuffs as healed (Y) or not healed (N), or the evaluator indicated that it was not possible to determine.	Performed at one week, six weeks, and six months after surgery
Comparison of Change in Dyspareunia	Dyspareunia will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using the sexual pain and discomfort domain (four questions) from the validated Female Sexual Function Index (FSFI). Individual success is defined as non-increase in dyspareunia from baseline to six months. Data analyzed "as treated".	Evaluated through twelve-month follow-up
Comparison of Change in Pain	Patient pain will be pre-operatively baselined and assessed at each follow-up timepoint, including any unexpected visits, using a validated 11-point numerical rating scale (no pain: 0 - the most pain: 10). Individual success is defined as non-increase in pain between baseline and six months. Fisher's Exact Test will be used to compare this measure between Test and Reference groups.	Six-months post-operative and again at 12 months post-operative

Collaborators and Investigators

• Sponsor: ZSX Medical LLC
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Paul Gilman, MD, Main Line Health

Publications and helpful links

Helpful Links

• ZSX Medical website

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): May 10, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Hysterectomy; Laparoscopic hysterectomy; minimally invasive hysterectomy
• Other Study ID Numbers: QD-PRO-054 Rev006; R44HD104539 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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