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

Total Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310658
• Other study ID #: ZHP01-1.0
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: October 2017
• Source: ZSX Medical LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Laparoscopic Hysterectomy

Intervention

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.

Locations

Country	Name	City	State
Mexico	Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey	Monterrey	Nuevo León

Sponsors (1)

Lead Sponsor	Collaborator
ZSX Medical LLC

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vaginal Cuff Closure	Assessment of quality of vaginal cuff closure following uterine excision. Performed by surgeon as operative standard of care.	During procedure.
Secondary	Vaginal Cuff Closure Time	Procedural time from uterine excision to successful vaginal cuff closure.	During Procedure.
Secondary	Total Surgical Time	Total procedural time.	During Procedure.
Secondary	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.
Secondary	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.