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Completed

NCT Number: NCT03310658

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

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.

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Key information

Conditions

Total Laparoscopic Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zip-Stitch Soft Tissue Closure System

Device

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.

Primary outcomes

  1. Device Ease of Use

    Time frame: Immediately following procedure

    Ease of Use of the Zip-Stitch Soft Tissue Closure System during Total Laparoscopic Hysterectomy. Assessed following surgery by standardized surgeon interview.

Secondary outcomes

  1. Vaginal Cuff Closure

    Time frame: During procedure.

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

  2. Vaginal Cuff Closure Time

    Time frame: During Procedure.

    Procedural time from uterine excision to successful vaginal cuff closure.

  3. Total Surgical Time

    Time frame: During Procedure.

    Total procedural time.

  4. Device Use Learning Curve assessed with a Surgeon Survey

    Time frame: Assessed immediately following study completion during surgeon survey.

    Investigation of change in effectiveness of device implementation as assessed by change in efficiency of device use.

  5. Sexual Discomfort

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

    Measurement of subject discomfort during sexual activity following completion of surgical procedure. Assessed with 1-10 scale (1 = No Pain, 10 = Most Pain).

Sponsors and collaborators

Lead sponsor

ZSX Medical LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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