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Suture
Zip-Stitch® for Laparoscopic Hysterectomy Procedures (ZIMS Trial)
N/A
Recruiting
Led By David Holtz, MD
Research Sponsored by ZSX Medical LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated through six-month follow-up
Awards & highlights
ZIMS Trial Summary
This trial will compare the safety and effectiveness of a new vaginal cuff closure system to a standard system. The primary outcome measure is the frequency of implant passing following system use.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here for Zip-stitch®, typical risks may include infection at the surgery site, pain or discomfort from the device itself, allergic reactions to materials in Zip-stitch®, and potential complications related to improper closure.
ZIMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ performed at one week, six weeks, and six months after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed at one week, six weeks, and six months after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Closure, Hospital
Safety: The primary safety endpoint in this study is frequency of vaginal cuff dehiscence.
Secondary outcome measures
Comparison of Incidence of Adverse Events - Test to Reference
Comparison of Number of Participants With Implant Passing - Test to Reference
Number of Participants With Non-increase in Dyspareunia at Follow-up
+4 moreZIMS Trial Design
2Treatment groups
Experimental Treatment
Group I: Test Article - Zip-stitch ClipsExperimental Treatment1 Intervention
Zip-stitch clips for vaginal cuff closure during laparoscopic hysterectomy
Group II: Reference GroupExperimental Treatment1 Intervention
Will not be comparative against the test article, but will be performed for reference and safety.
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Who is running the clinical trial?
ZSX Medical LLCLead Sponsor
2 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Laparoscopic Hysterectomy
2 Patients Enrolled for Laparoscopic Hysterectomy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,671 Total Patients Enrolled
David Holtz, MDPrincipal InvestigatorMain Line Health
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Eligibility Criteria:
This trial includes the following eligibility 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.I am currently taking corticosteroids.I am currently on blood thinner medication.During surgery, the surgeon couldn't find enough tissue to stitch up with the laparoscope.I have a known clotting defect or bleeding disorder.My surgery was changed to an open procedure before the study treatment.I have an active infection in my reproductive or urinary system.I have had Hepatitis C in the past.I do not have an active severe infection.I currently have a sexually transmitted infection.My cancer has spread to other parts of my body.I am a woman aged 18 or older.I am scheduled for a laparoscopic or robotic-assisted hysterectomy.I have a history of HIV.I am willing to follow all study rules and attend all visits, including phone calls.My bowel was injured during a keyhole surgery to remove my uterus.
Research Study Groups:
This trial has the following groups:- Group 1: Test Article - Zip-stitch Clips
- Group 2: Reference Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there capacity for more participants in this research endeavor?
"The clinical trial portal shows that this particular medical study is not presently accepting patients. Initially posted on January 1st 2023, the last update was made October 6th 2022. However, there are currently two other trials actively recruiting patient participants."
Answered by AI
What core goals does this trial seek to accomplish?
"This medical trial seeks to assess the efficacy of its intervention by evaluating frequency of implant passing following cuff closure. Moreover, secondary outcomes such as binary visual surgeon cuff healing evaluation, non-increase in reported individual subject pain from baseline to six-month follow-up (measured utilizing an 11 point numerical rating scale), and percentage of participants with implant passing events determined to impact patient safety will be compared between test and reference groups over a 6 week postoperative period."
Answered by AI
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