Laparoscopic HysterectomyZIMSNCT05570916
Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
A study testing Zip-stitch(R) and Reference suture in people with Laparoscopic Hysterectomy, run by ZSX Medical LLC at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Zip-stitch(R) and Reference suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Aug 2023to 10 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northwestern University
Chicago, Illinois, 60611
Mon Health Medical Center
Morgantown, West Virginia, 26505
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
Unified Women's Clinical Research
Winston-Salem, North Carolina, 27103
Lankenau Hospital
Wynnewood, Pennsylvania, 19096
About this study
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.
Read the 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.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Zip-stitch(R), Reference suture
- Keywords
- Hysterectomy, Laparoscopic hysterectomy, minimally invasive hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip-stitch(R)Device
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Reference sutureDevice
Also called V-Loc or VICRYL sutures
Standard suture for vaginal cuff closure during laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Test Article - Zip-stitch Clips | Experimental | Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy Receives: Device: Zip-stitch(R) |
| Reference Group | Other | Will not be comparative against the test article, but will be performed for reference and safety. Receives: Device: Reference suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: This will be evaluated through six weeks post operative.
Secondary outcomes (7)
Number of Participants With Successful Vaginal Cuff Closure
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).
Measured: Performed intra-operatively and at one week, six weeks, and six months after surgery
Number of Participants With Healed Vaginal Cuffs
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.
Measured: Performed at one week, 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.
Measured: 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.
Measured: 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.
Measured: Evaluated through six-month follow-up
Comparison of Change in Dyspareunia
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".
Measured: Evaluated through twelve-month follow-up
Comparison of Change in Pain
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.
Measured: Six-months post-operative and again at 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start17 Aug 2023
- Primary completion12 Nov 2024
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZSX Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Paul Gilman, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570916
- Sponsor's protocol ID
- QD-PRO-054 Rev006
- Other IDs
- R44HD104539
- Acronym
- ZIMS
- Status last verified
- Sep 2025
- First submitted
- 4 Oct 2022
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No