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

NCT05570916 | Completed Results DMC FDA Device

• 2 other identifiers: QD-PRO-054 Rev006R44HD104539
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Laparoscopic Hysterectomy

Keywords

Hysterectomy; Laparoscopic hysterectomy; minimally invasive hysterectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Number of Participants With Successful Vaginal Cuff Closure

  Performed intra-operatively and at one week, six weeks, and six months after surgery

• Number of Participants With Healed Vaginal Cuffs

  Performed at one week, six weeks, and six months after surgery

• Comparison of Number of Participants With Implant Passing - Test to Reference

  Evaluated at six weeks and six months post-operative

• Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety

  Evaluated through six-month follow-up

• Comparison of Incidence of Adverse Events - Test to Reference

  Evaluated through six-month follow-up

Study Arms (2)

Test Article - Zip-stitch Clips

EXPERIMENTAL

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Device: Zip-stitch(R)

Reference Group

OTHER

Will not be comparative against the test article, but will be performed for reference and safety.

Device: Reference suture

Interventions

Zip-stitch(R) DEVICE

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Test Article - Zip-stitch Clips

Reference suture DEVICE

Standard suture for vaginal cuff closure during laparoscopic hysterectomy

Also known as: V-Loc or VICRYL sutures

Reference Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)

You may not qualify if:

• History of Human Immunodeficiency Virus (HIV)
• History of Hepatitis C
• History of diabetes that, in the opinion of the investigator, may delay healing
• Current use of systemic corticosteroids
• Active infection of genitals, vagina, cervix, uterus or urinary tract
• Active bacteremia, sepsis or other active systemic infection
• Presence of Sexually Transmitted Infection (STI)
• Evidence of pelvic inflammatory disease (PID)
• Known clotting defects or bleeding disorders
• Hemoglobin \< 8 g/dL
• Metastatic disease
• On anticoagulant therapy
• Participation in another interventional trial
• Pregnancy
• Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing

Sponsors & Collaborators

• ZSX Medical LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Unified Women's Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Tidewater Clinical Research

Virginia Beach, Virginia, 23456, United States

Location

Mon Health Medical Center

Morgantown, West Virginia, 26505, United States

Location

Related Links

• ZSX Medical website

Limitations and Caveats

The study was stopped after enrolling 23 subjects out of a planned 59, so the expected statistical power was not reached. In addition, it was seen that a more objective means to evaluate both "cuff closure" and "cuff healing" was needed.

Results Point of Contact

• Title: Dan Mazzucco
• Organization: ZSX Medical

dmazzucco@zsxmedical.com

617-631-8865

Study Officials

• Paul Gilman, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 7, 2022
• Study Start: August 17, 2023
• Primary Completion: November 12, 2024
• Study Completion: May 10, 2025
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)