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Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

Intrauterine Adhesion Clinical Trial

Official title:
Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions: A Multicenter Randomized Controlled Subject and Evaluator Blinded Pivotal Study

Clinical Trial Summary

This study is to determine whether intrauterine instillation of Juveena hydrogel following adhesiogenic hysteroscopic procedures (TCGP + Juveena) can safely and effectively reduce the incidence and severity of intrauterine adhesions (IUA) compared to TCGP alone.

Clinical Trial Description

This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05394662
Study type Interventional
Source Rejoni Inc.
Contact Ian Feldberg
Phone 978-760-1742
Email patientinfo@juveena.com
Status Recruiting
Phase Phase 3
Start date August 11, 2022
Completion date March 15, 2025
View Details
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