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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Standard suture for vaginal cuff closure during laparoscopic hysterectomy
Northwestern University
Chicago, Illinois, United States
Unified Women's Clinical Research
Winston-Salem, North Carolina, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Tidewater Clinical Research
Virginia Beach, Virginia, United States
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.
Frequency of vaginal cuff dehiscence
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.
Frequency of implant passing
Time frame: This will be evaluated through six weeks post operative.
Number of Participants With Successful Vaginal Cuff Closure
Binary, visual surgeon cuff closure evaluation.
Time frame: Performed at one week, six weeks, and six months after surgery
Number of Participants With Vaginal Cuff Healing
Binary, visual surgeon cuff healing evaluation.
Time frame: 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.
Time frame: 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.
Time frame: Evaluated through six-month follow-up
Comparison of Incidence of Adverse Events - Test to Reference
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Mon Health Medical Center
Morgantown, West Virginia, United States
Adverse events and serious adverse events will be tabulated for both the test and reference groups.
Time frame: 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.
Time frame: 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.
Time frame: Evaluated through six-month follow-up