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

NCT05570916 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: QD-PRO-054 Rev006R44HD104539
• Study Type: interventional
• Target: 59
• 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)

• 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 Outcomes (7)

• Number of Participants With Successful Vaginal Cuff Closure

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

• Number of Participants With Vaginal Cuff Healing

  Performed at 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: Yes
• 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

Study Officials

• David Holtz, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

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: June 12, 2024
• Study Completion: May 10, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)