Status:
COMPLETED
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
Lead Sponsor:
ZSX Medical LLC
Conditions:
Total Laparoscopic Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03310658
Start Date
April 17 2017
End Date
May 30 2018
Last Update
September 4 2018
Active Locations (1)
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1
Hospital Universitario: Universidad Autónoma de Nuevo León de Monterrey
Monterrey, Nuevo León, Mexico, 64460