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

Last updated: November 13, 2024
Sponsor: ZSX Medical LLC
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Zip-stitch(R)

Reference suture

Clinical Study ID

NCT05570916
QD-PRO-054 Rev006
R44HD104539
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated Informed Consent Form 2. Stated willingness to complywith all study procedures, including participation in follow-up visits andtelephonic follow-up 3. Female 18 years and older 5. Indicated for LaparoscopicHysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic AssistedVaginal Hysterectomy, or robotic assisted vaginal hysterectomy)

Exclusion

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 inthe opinion of the investigator may indicate abnormal vaginal cuff healing

  16. Co-morbidities that, in the opinion of the investigator, may indicate risk ofabnormal vaginal cuff healing

  17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior toattempted cuff closure

  18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior toattempted cuff closure

  19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along thecuff to apply suture laparoscopically

  20. Intra-operative: Cases requiring conversion to laparotomy prior to studyintervention

Study Design

Total Participants: 59
Treatment Group(s): 2
Primary Treatment: Zip-stitch(R)
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
May 10, 2025

Study 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.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Unified Women's Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lankenau Hospital

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Tidewater Clinical Research

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Mon Health Medical Center

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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