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Completed

NCT Number: NCT05570916

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

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.

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Key information

Conditions

Laparoscopic Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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
  • Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing
  • Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
  • Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
  • Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically
  • Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

Treatment and study plan

Zip-stitch(R)

Device

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Reference suture

Device

Standard suture for vaginal cuff closure during laparoscopic hysterectomy

Other names: V-Loc or VICRYL sutures

Primary outcomes

  1. Vaginal Cuff Dehiscence Rate

    Time frame: This will be evaluated through six-weeks post-operative.

    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.

  2. Number of Participants With Implant Passing Through Six Weeks

    Time frame: 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. 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.

Secondary outcomes

  1. Number of Participants With Successful Vaginal Cuff Closure

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

    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).

  2. Number of Participants With Healed Vaginal Cuffs

    Time frame: Performed at one week, six weeks, and six months after surgery

    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.

  3. Comparison of Number of Participants With Implant Passing - Test to Reference

    Time frame: Evaluated at six weeks and six months post-operative

    Percentage of subjects experiencing implant passing will be compared between test and reference groups.

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

    Time frame: Evaluated through six-month follow-up

    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.

  5. Comparison of Incidence of Adverse Events - Test to Reference

    Time frame: Evaluated through six-month follow-up

    Adverse events and serious adverse events will be tabulated for both the test and reference groups.

  6. Comparison of Change in Dyspareunia

    Time frame: Evaluated through twelve-month follow-up

    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".

  7. Comparison of Change in Pain

    Time frame: Six-months post-operative and again at 12 months post-operative

    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.

Sponsors and collaborators

Lead sponsor

ZSX Medical LLC

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: ZIMS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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