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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Show all 20Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy
- ClinicalTrials.gov ID
- NCT05570916
- Acronym / sponsor ID
- ZIMS / QD-PRO-054 Rev006
- Conditions
- Laparoscopic Hysterectomy
- Keywords
- Hysterectomy, Laparoscopic hysterectomy, minimally invasive hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ZSX Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Article - Zip-stitch Clips | Experimental | Device: Zip-stitch(R)Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy |
| Reference Group | Other | Device: Reference sutureWill not be comparative against the test article, but will be performed for reference and safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zip-stitch(R)Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy | Device | Test Article - Zip-stitch Clips |
| Reference sutureAlso: V-Loc or VICRYL suturesStandard suture for vaginal cuff closure during laparoscopic hysterectomy | Device | Reference Group |
Primary outcome
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.
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.
7 secondary outcomes
Number of Participants With Successful Vaginal Cuff Closure
Time frame: Performed intra-operatively and at one week, six weeks, and six months after surgery
Number of Participants With Healed Vaginal Cuffs
Time frame: Performed at one week, six weeks, and six months after surgery
Comparison of Number of Participants With Implant Passing - Test to Reference
Time frame: Evaluated at six weeks and six months post-operative
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
Time frame: Evaluated through six-month follow-up
Comparison of Incidence of Adverse Events - Test to Reference
Time frame: Evaluated through six-month follow-up
Comparison of Change in Dyspareunia
Time frame: Evaluated through twelve-month follow-up
Comparison of Change in Pain
Time frame: Six-months post-operative and again at 12 months post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ZSX Medical websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Gilman, MD principal investigator
Main Line Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Cuff Dehiscence Rate (time frame: This will be evaluated through six-weeks post-operative.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.