Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device. Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.

Official Title
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Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study

Conditions
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Total Laparoscopic Hysterectomy

Intervention / Treatment
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* Device: Zip-Stitch Soft Tissue Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated Informed Consent Form Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up Female, age 18 years or older Indicated for Total Laparoscopic Hysterectomy Exclusion Criteria: HIV Hepatitis C Diabetics Use of systemic corticosteroids History of pelvic irradiation Active infection History of bleeding problems/hemophilia Cancer Cases in which vaginal cuff closure is intended to be performed robotically Pregnant

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Study Site: UANL<br>As the only study arm, 10 enrolled subjects received vaginal cuff closure with the Zip-Stitch Soft Tissue Closure System as part of Total Laparoscopic Hysterectomy. | Device: Zip-Stitch Soft Tissue Closure System<br>* The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Ease of Use | Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview. | Immediately following procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Cuff Closure | Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care. | During procedure. | 
| Vaginal Cuff Closure Time | Procedural time from uterine excision to successful vaginal cuff closure. | During Procedure. | 
| Total Surgical Time | Total procedural time. | During Procedure. | 
| Device Use Learning Curve assessed with a Surgeon Survey | Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use. | Assessed immediately following study completion during surgeon survey. | 
| Sexual Discomfort | Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain). | Assessed at 1 and 6 week follow-up visits. |