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

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ClinicalTrials.gov Identifier: NCT03310658
Recruitment Status : Completed
First Posted : October 16, 2017
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
ZSX Medical LLC

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Total Laparoscopic Hysterectomy Device: Zip-Stitch Soft Tissue Closure System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy: First in Human Ease of Use Study
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Single Study Site: UANL
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
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 Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310658


Locations
Mexico
Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
ZSX Medical LLC
Investigators
Study Director: Dan Mazzucco, PhD ZSX Medical LLC

Responsible Party: ZSX Medical LLC
ClinicalTrials.gov Identifier: NCT03310658     History of Changes
Other Study ID Numbers: ZHP01-1.0
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes