Clinical Trials Logo
  1. Home
  2. Laparoscopic Hysterectomy
  3. NCT05570916

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

Laparoscopic Hysterectomy Clinical Trial

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

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05570916
Study type Interventional
Source ZSX Medical LLC
Contact Samantha Sam, BS
Phone 8566492579
Email ssam@zsxmedical.com
Status Recruiting
Phase N/A
Start date August 17, 2023
Completion date September 1, 2025
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06050161 - Evaluating Artisential Laparoscopic Instruments in Gynecologic Surgery N/A
Terminated NCT04081727 - Zip-Stitch™ for Vaginal Cuff Closure in Laparoscopic Hysterectomy - Safety & Efficacy Study N/A
Recruiting NCT05645809 - Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery N/A
Completed NCT04239547 - Effects of Recruitment Maneuver During Intraoperative Period N/A
Completed NCT03144414 - Laparoscopic Assisted Doderlin Vaginal Hysterectomy N/A
Completed NCT03126162 - Postoperative Bladder Testing After Total Laparoscopic Hysterectomy N/A
Completed NCT02908841 - Surgicel Snow in Gynecological Surgery N/A
Completed NCT04972682 - [SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer N/A
Completed NCT02065453 - Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy N/A
Recruiting NCT05826119 - Intravenous Administration of Magnesium Sulfate in Laparoscopic Hysterectomy Cases N/A
Completed NCT04366375 - Pentraxin-3 in Hysterectomy Patients
Completed NCT03418402 - Post Operative Pain After Laparoscopic Hysterectomy Using Airseal® Versus Standard Insufflation System N/A
Completed NCT05690087 - Lidocaine Infusion on Optic Nerve Sheath Diameter in Laparoscopic Hysterectomy in Trendelenburg Position N/A
Completed NCT03350334 - Perioperative Duloxetine for Pain Management After Laparoscopic Hysterectomy N/A
Terminated NCT04725981 - Vaginal Stump Infection After Laparoscopic Hysterectomy N/A
Completed NCT01344499 - Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum N/A
Completed NCT01578759 - Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian Function N/A