Zip-Stitch® for Laparoscopic Hysterectomy Procedures

(ZIMS Trial)

Recruiting at 4 trial locations

Overseen By Samantha Sam, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: ZSX Medical LLC

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: HIV, Hepatitis C, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: Immediate post-operative period

59 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Holtz, MD

Principal Investigator

Main Line Health

Eligibility Criteria

This trial is for women aged 18 or older who need a laparoscopic hysterectomy, which includes total, assisted vaginal, or robotic-assisted types. Participants must consent to follow-up procedures and not have active infections, HIV, bleeding disorders, low hemoglobin levels, metastatic disease, pregnancy or certain other conditions that could affect healing.

Inclusion Criteria

Provision of signed and dated Informed Consent Form

I am a woman aged 18 or older.

I am scheduled for a laparoscopic or robotic-assisted hysterectomy.

Exclusion Criteria

I have been diagnosed with pelvic inflammatory disease.

My doctor is concerned about how my vaginal cuff might heal due to other health issues.

My bladder was injured during a keyhole surgery to remove my uterus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally-invasive hysterectomy with Zip-stitch® system for vaginal cuff closure

Immediate post-operative period

Blinded Follow-up

Blinded follow-up to evaluate implant passing, successful cuff closure, healing, adverse events, dyspareunia, and pain

6 weeks

In-person visits at 1 week and 6 weeks

Unblinded Follow-up

Unblinded follow-up to assess long-term outcomes including implant passing and adverse events

6 months

In-person visit at 6 months

Extended Follow-up

Extended follow-up to monitor long-term safety and efficacy outcomes

12 months

Telephone follow-up at 12 months

Treatment Details

Interventions

• Reference suture
• Zip-stitch(R)

Trial Overview The study tests the safety and effectiveness of Zip-stitch® Vaginal Cuff Closure System compared to standard suturing in closing the vagina after a hysterectomy. The main focus is on how often the implant passes through tissue with additional safety and efficacy comparisons made against a reference group.

Participant Groups

Group I: Test Article - Zip-stitch Clips Experimental Treatment 1 Intervention

Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy

Group II: Reference Group Experimental Treatment 1 Intervention

Will not be comparative against the test article, but will be performed for reference and safety.

Who Is Running the Clinical Trial?

ZSX Medical LLC

Lead Sponsor

Trials

3

Recruited

70+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+