Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

Laparoscopic Hysterectomy Clinical Trial

— ZIMS  

Official title:

Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & Efficacy in Hysterectomy

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
• 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
• 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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

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