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

Not Applicable

Terminated

Conditions: Laparoscopic Hysterectomy

Interventions: Device: Zip-stitch(TM)

Registration Number: NCT04081727

Lead Sponsor: ZSX Medical LLC

Brief 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. 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 2

Inclusion Criteria

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Group - V-Loc Barbed Suture	Zip-stitch(TM)	Will not be comparative against the test article, but will be performed for reference and safety.
Test Article - Zip-stitch Clips	Zip-stitch(TM)	Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Vaginal Cuff Healing	Performed at one week, six weeks, and six months after surgery; reported here at six weeks	Binary, visual surgeon cuff healing evaluation
Number of Participants With Successful Vaginal Cuff Closure	Performed at one week, six weeks, and six months after surgery; reported here at six weeks	Binary, visual surgeon cuff closure evaluation
Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety	Evaluated after one week, six week, six month, and twelve month follow-up	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.
Number of Participants With Non-increase in Dyspareunia at Follow-up	Six-months post-operative and again at 12 months post-operative	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.
Comparison of Number of Participants With Implant Passing - Test to Reference	evaluated at six months post-operative	Percentage of subjects experiencing implant passing will be compared between test and reference groups
Comparison of Incidence of Adverse Events - Test to Reference	Evaluated after one week, six week, six month, and twelve month follow-up; reported here for all time	Adverse events and serious adverse events will be tabulated for both the test and reference groups.
Number of Participants With Non-increase in Pain at Follow-up	Six-months post-operative and again at 12 months post-operative; count is number of subjects with non-increase	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.