Laparoscopic HysterectomyNCT04081727
Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
A study testing Zip-stitch(TM) in people with Laparoscopic Hysterectomy, run by ZSX Medical LLC at 1 site 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 onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Zip-stitch(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 22 Jun 2021
- 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
- Healthy volunteers accepted
- 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 (may include TLH, LAVH, robotic assisted vaginal hysterectomy)
Who cannot join
- History of 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 18Show 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 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-op: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure
- 16. Intra-op: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 17. Intra-op: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 18. Intra-op: Cases requiring conversion to laparotomy prior to study intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Lankenau Medical Center
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 (V-LOC barbed suture).
Read the detailed description
This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.
- Conditions
- Laparoscopic Hysterectomy
- Being tested
- Zip-stitch(TM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zip-stitch(TM)Device
The assigned intervention is used to close the cuff following colpotomy.
| 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(TM) |
| Reference Group - V-Loc Barbed Suture | Other | Will not be comparative against the test article, but will be performed for reference and safety. Receives: Device: Zip-stitch(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint - Number of Participants With Implant Passing
Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks
Measured: Six-weeks post-operative
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.
Measured: Six-weeks post-operative
Secondary outcomes (7)
Number of Participants With Successful Vaginal Cuff Closure
Binary, visual surgeon cuff closure evaluation
Measured: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Number of Participants With Vaginal Cuff Healing
Binary, visual surgeon cuff healing evaluation
Measured: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
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 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 after one week, six week, six month, and twelve 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 after one week, six week, six month, and twelve month follow-up; reported here for all time
Number of Participants With Non-increase in Dyspareunia at Follow-up
Non-increase in reported individual subject dyspareunia from baseline to follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups.
Measured: Six-months post-operative and again at 12 months post-operative
Number of Participants With Non-increase in Pain at Follow-up
Non-increase in reported individual subject pain from baseline to follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain.
Measured: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start6 Nov 2019
- Primary completion31 Aug 2020
- Study completion22 Jun 2021
Why it stopped: After the second surgery, enrollment was stopped for reasons unrelated to the study design or test article.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZSX Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David O Holtz, M.D., Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081727
- Sponsor's protocol ID
- QD-PRO-045 Rev002
- Status last verified
- Aug 2022
- First submitted
- 4 Sep 2019
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study
- ClinicalTrials.gov ID
- NCT04081727
- Acronym / sponsor ID
- QD-PRO-045 Rev002
- Conditions
- Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After the second surgery, enrollment was stopped for reasons unrelated to the study design or test article.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- ZSX Medical LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 7 Sep 2022
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 (V-LOC barbed suture).
Detailed description
This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure following laparoscopic 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, six weeks, and six months. There will be an additional unblinded follow-up by telephone at 12 months post operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Article - Zip-stitch Clips | Experimental | Device: Zip-stitch(TM)Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy |
| Reference Group - V-Loc Barbed Suture | Other | Device: Zip-stitch(TM)Will 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
- 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 (may include TLH, LAVH, robotic assisted vaginal hysterectomy)
Key exclusion criteria (18 listed)
- History of 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(TM)The assigned intervention is used to close the cuff following colpotomy. | Device | Reference Group - V-Loc Barbed Suture, Test Article - Zip-stitch Clips |
Primary outcome
Primary Efficacy Endpoint - Number of Participants With Implant Passing
Time frame: Six-weeks post-operative
Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks
Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence
Time frame: Six-weeks post-operative
Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure.
7 secondary outcomes
Number of Participants With Successful Vaginal Cuff Closure
Time frame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Number of Participants With Vaginal Cuff Healing
Time frame: Performed at one week, six weeks, and six months after surgery; reported here at six weeks
Comparison of Number of Participants With Implant Passing - Test to Reference
Time frame: evaluated at six months post-operative
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety
Time frame: Evaluated after one week, six week, six month, and twelve month follow-up
Comparison of Incidence of Adverse Events - Test to Reference
Time frame: Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time
Number of Participants With Non-increase in Dyspareunia at Follow-up
Time frame: Six-months post-operative and again at 12 months post-operative
Number of Participants With Non-increase in Pain at Follow-up
Time frame: Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David O Holtz, M.D. principal investigator
Main Line Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zip-stitch(TM) in people with Laparoscopic Hysterectomy, run by ZSX Medical LLC at 1 site 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 18 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: stopped early, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Sep 2022). 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?
Primary Efficacy Endpoint - Number of Participants With Implant Passing (time frame: 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 7 Sep 2022.