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: Recruiting
• 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 (Estimated): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan O Mazzucco, PhD; Phone Number: 2157043728; Email: dmazzucco@zsxmedical.com
• Study Contact Backup: Name: Samantha Sam, BS; Phone Number: 8566492579; Email: ssam@zsxmedical.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Anne Grace, PhD; Email: anne@northwestern.edu
      • Principal Investigator: Emily Hinchcliff, MD, MPH
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Unified Women's Clinical Research
      • Contact: Madelyn Biffle; Phone Number: 336-397-3716; Email: Madelyn.Biffle@unifiedhc.com
      • Principal Investigator: Lamar Parker, MD
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Lankenau Hospital
      • Contact: David O Holtz, M.D; Phone Number: 610-560-8940; Email: holtzd@mlhs.org
  • Virginia
    • Virginia Beach, Virginia, United States, 23456
      • Active, not recruiting
      • Tidewater Clinical Research
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • Mon Health Medical Center
      • Contact: Rebecca Greenwood; Phone Number: 304-598-6581; Email: Rebecca.Greenwood@vandaliahealth.org
      • Principal Investigator: William McBee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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: Double

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
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.	Frequency of vaginal cuff dehiscence	This will be evaluated through six-weeks post-operative.
Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure.	Frequency of implant passing	This will be evaluated through 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
Number of Participants With Vaginal Cuff Healing	Binary, visual surgeon cuff healing evaluation.	Performed at six weeks, and six months after surgery
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 Non-increase in Dyspareunia at Follow-up	Non-increase in reported individual subject dyspareunia from baseline to six month 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.	Evaluated through six-month follow-up
Number of Participants With Non-increase in Pain at Follow-up	Non-increase in reported individual subject pain from baseline to six-month 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.	Evaluated through six-month follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 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): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: QD-PRO-054 Rev001; 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