Zip-Stitch® for Laparoscopic Hysterectomy Procedures

(ZIMS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Zip-stitch® for women undergoing a laparoscopic hysterectomy, a surgical procedure to remove the uterus. The goal is to determine if this tool safely and effectively closes the vaginal cuff, the area stitched during surgery. Participants will use either the new Zip-stitch® clips or a standard suture for comparison. Women planning a laparoscopic hysterectomy without certain health issues, such as diabetes or infections, might be suitable for this trial. As an unphased study, this trial allows participants to contribute to innovative surgical advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant therapy or systemic corticosteroids.

What prior data suggests that the Zip-stitch® Vaginal Cuff Closure System is safe for laparoscopic hysterectomy procedures?

Research has shown that the Zip-stitch® Vaginal Cuff Closure System safely and effectively closes tissues during surgery. It uses clips that the body absorbs over time, eliminating the need for another procedure to remove them.

The Zip-stitch system has been well-received, with no serious side effects reported in earlier studies, suggesting it is generally safe for surgeries like laparoscopic hysterectomies. However, discussing any concerns with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Zip-Stitch® clips for laparoscopic hysterectomy procedures because they offer a novel method for closing the vaginal cuff. Unlike traditional sutures, which can be time-consuming and technically challenging, Zip-Stitch® provides a simpler and potentially faster closure technique. This innovative approach may reduce surgery time and improve patient outcomes by minimizing complications like infections. By streamlining the closure process, Zip-Stitch® aims to enhance the efficiency and safety of laparoscopic hysterectomies.

What evidence suggests that the Zip-stitch® Vaginal Cuff Closure System is effective for laparoscopic hysterectomy procedures?

Research shows that the Zip-stitch® Vaginal Cuff Closure System helps surgeons close the vaginal cuff more quickly and easily during laparoscopic hysterectomy. In this trial, participants will join different treatment arms to evaluate the Zip-stitch® system. Studies have found that this system reduces the time needed for the procedure. Although patient outcomes remain similar regardless of the closure method, the Zip-stitch® system offers a practical advantage through increased efficiency. This efficiency makes it a potentially useful tool in surgeries involving vaginal cuff closure. Ongoing research continues to focus on the safety and effectiveness of the system. ^{1 2 3 4 6}

Who Is on the Research Team?

David Holtz, MD

Principal Investigator

Main Line Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04081727/Prot_SAP_000.pdf

Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic ... The Zip-stitch™ system is designed to reduce the time and difficulty of cuff closure during laparoscopic hysterectomy by enabling surgeons to ...

2. ctv.veeva.com ctv.veeva.com/study/zip-stitch-r-in-minimally-invasive-surgery-zims-safety-efficacy-in-hysterectomy

Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05570916/zip-stitchr-in-minimally-invasive-surgery-zims-safety-efficacy-in-hysterectomy

Zip-Stitch® in Minimally-Invasive Surgery (ZIMS) - Safety & ... The primary objective of this study is to evaluate the safety and efficacy of the Zip-stitch® Vaginal Cuff Closure System.

4. mainlinehealth.org mainlinehealth.org/research/clinical-trials/zipstitch

Safety & Efficacy in Hysterectomy (ZIMS) | Clinical Trials 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27923167/

Long-term outcomes for different vaginal cuff closure ... The type of closure technique has no significant impact on patient outcomes. In the absence of a clear advantage of one technique over the others, ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04081727?keyword=%22Laparoscopic%22

Zip-Stitchâ„¢ for Vaginal Cuff Closure in Laparoscopic ... This is a prospective, blinded, randomized, controlled study to assess the safety and efficacy of the Zip-stitch™ System in maintaining vaginal cuff closure ...