Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy
Sponsored by ZSX Medical LLC
About this trial
Last updated 7 years ago
Study ID
ZHP01-1.0
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
Female
Not accepting
Healthy Volunteers
Trial Timing
Ended 7 years ago
What is this trial about?
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.
What are the participation requirements?
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