Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study

Conditions
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Laparoscopic Hysterectomy

Intervention / Treatment
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* Device: Zip-stitch(TM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Article - Zip-stitch Clips<br>Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy | Device: Zip-stitch(TM)<br>* The assigned intervention is used to close the cuff following colpotomy.<br>|
| Other: Reference Group - V-Loc Barbed Suture<br>Will not be comparative against the test article, but will be performed for reference and safety. | Device: Zip-stitch(TM)<br>* The assigned intervention is used to close the cuff following colpotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint - Number of Participants With Implant Passing | Frequency of implant passing following laparoscopic vaginal cuff closure within six weeks | Six-weeks post-operative | 
| Primary Safety Endpoint - Number of Participants With Vaginal Cuff Dehiscence | Frequency of Vaginal Cuff Dehiscence following laparoscopic vaginal cuff closure. | Six-weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Vaginal Cuff Closure | Binary, visual surgeon cuff closure evaluation | 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 | 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 | 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. | 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. | 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. | 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. | Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase |