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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05570916
Other study ID # QD-PRO-054 Rev001
Secondary ID R44HD104539
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2023
Est. completion date September 1, 2025

Study information

Verified date March 2024
Source ZSX Medical LLC
Contact Samantha Sam, BS
Phone 8566492579
Email ssam@zsxmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System. This will be primarily done by measuring the frequency of implant passing following system use. Also assessed will be relevant safety and efficacy endpoints as compared to a two-to-one reference group.


Description:

This study is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip stitch® System in maintaining vaginal cuff closure following minimally-invasive hysterectomy. Participating subjects will be randomized and evaluated for implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain. Blinded follow-up will involve in-person visits at one week and six weeks. There will be additional unblinded follow-up in person at six months post-operatively and by telephone at 12 months post operatively.


Recruitment information / eligibility

Status Recruiting
Enrollment 59
Est. completion date September 1, 2025
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated Informed Consent Form 2. Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up 3. Female 18 years and older 5. Indicated for Laparoscopic Hysterectomy (includes Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, or robotic assisted vaginal hysterectomy) Exclusion Criteria: 1. History of Human Immunodeficiency Virus (HIV) 2. History of Hepatitis C 3. History of diabetes that, in the opinion of the investigator, may delay healing 4. Current use of systemic corticosteroids 5. Active infection of genitals, vagina, cervix, uterus or urinary tract 6. Active bacteremia, sepsis or other active systemic infection 7. Presence of Sexually Transmitted Infection (STI) 8. Evidence of pelvic inflammatory disease (PID) 9. Known clotting defects or bleeding disorders 10. Hemoglobin < 8 g/dL 11. Metastatic disease 12. On anticoagulant therapy 13. Participation in another interventional trial 14. Pregnancy 15. Abnormal Papanicolaou test (PAP) results that have not been fully evaluated, or in the opinion of the investigator may indicate abnormal vaginal cuff healing 16. Co-morbidities that, in the opinion of the investigator, may indicate risk of abnormal vaginal cuff healing 17. Intra-operative: Bowel injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 18. Intra-operative: Bladder injury during laparoscopic hysterectomy procedure prior to attempted cuff closure 19. Intra-operative: Cases in which surgeon cannot identify adequate tissue along the cuff to apply suture laparoscopically 20. Intra-operative: Cases requiring conversion to laparotomy prior to study intervention

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Zip-stitch(R)
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Reference suture
Standard suture for vaginal cuff closure during laparoscopic hysterectomy

Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States Mon Health Medical Center Morgantown West Virginia
United States Tidewater Clinical Research Virginia Beach Virginia
United States Unified Women's Clinical Research Winston-Salem North Carolina
United States Lankenau Hospital Wynnewood Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
ZSX Medical LLC Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence. Frequency of vaginal cuff dehiscence This will be evaluated through six-weeks post-operative.
Primary Efficacy: The primary efficacy endpoint for this study is frequency of implant passing following cuff closure. Frequency of implant passing This will be evaluated through six weeks post operative.
Secondary Number of Participants With Successful Vaginal Cuff Closure Binary, visual surgeon cuff closure evaluation. Performed at one week, six weeks, and six months after surgery
Secondary Number of Participants With Vaginal Cuff Healing Binary, visual surgeon cuff healing evaluation. Performed at six weeks, and six months after surgery
Secondary Comparison of Number of Participants With Implant Passing - Test to Reference Percentage of subjects experiencing implant passing will be compared between test and reference groups. Evaluated at six weeks and six months post-operative
Secondary Percentage of Participants With Implant Passing Events Determined to Impact Patient Safety Each reported implant passing event will be evaluated for association with adverse events. Compared as a percentage of patients in the test vs. reference groups. Evaluated through six-month follow-up
Secondary Comparison of Incidence of Adverse Events - Test to Reference Adverse events and serious adverse events will be tabulated for both the test and reference groups. Evaluated through six-month follow-up
Secondary Number of Participants With Non-increase in Dyspareunia at Follow-up Non-increase in reported individual subject dyspareunia from baseline to six month follow-up will be compared (test versus reference group) using the relevant sexual discomfort module of the Female Sexual Function Index (FSFI). The FSFI is a validated metric of female sexual function, where lower scores indicate poor sexual function. Non-increase in sexual discomfort will be compared between test and control groups. Evaluated through six-month follow-up
Secondary Number of Participants With Non-increase in Pain at Follow-up Non-increase in reported individual subject pain from baseline to six-month follow-up will be compared (test versus reference group) using an 11-point Numerical Rating Scale, where 0 indicates no pain, and 10 indicates maximum possible pain. Evaluated through six-month follow-up
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