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

ZSX Medical LLC10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Total Laparoscopic Hysterectomy

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Immediately following procedure

Secondary Outcomes

Vaginal Cuff Closure

Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.

Time frame: During procedure.

Vaginal Cuff Closure Time

Procedural time from uterine excision to successful vaginal cuff closure.

Time frame: During Procedure.

Total Surgical Time

Total procedural time.

Time frame: 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.

Time frame: 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).

Time frame: Assessed at 1 and 6 week follow-up visits.