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

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.

Detailed Description
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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.

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

Conditions
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Laparoscopic Hysterectomy

Intervention / Treatment
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* Device: Zip-stitch(R)
* Device: Reference suture


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 (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

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: Double


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(R)<br>* Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy<br>|
| Other: Reference Group<br>Will not be comparative against the test article, but will be performed for reference and safety. | Device: Reference suture<br>* Standard suture for vaginal cuff closure during laparoscopic hysterectomy<br>* Other names: V-Loc or VICRYL sutures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. | Frequency of vaginal cuff dehiscence | 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. | Frequency of implant passing | This will be evaluated through 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 | 
| Number of Participants With Vaginal Cuff Healing | Binary, visual surgeon cuff healing evaluation. | Performed at 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. | 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. | 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. | Evaluated through six-month follow-up | 
| Number of Participants With Non-increase in Dyspareunia at Follow-up | Non-increase in reported individual subject dyspareunia from baseline to six month 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. | Evaluated through six-month follow-up | 
| Number of Participants With Non-increase in Pain at Follow-up | Non-increase in reported individual subject pain from baseline to six-month 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. | Evaluated through six-month follow-up |