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Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions
Sponsor: Rejoni Inc.
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2022-08-11
Completion Date
2025-04-23
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Juveena Hydrogel System
Application of a novel hydrogel immediately following the transcervical procedure
Transcervical Gynecologic Procedures (TCGP)
Hysteroscopic adhesiolysis or hysteroscopic myomectomy
Locations (15)
Arizona Gynecology Consultants
Phoenix, Arizona, United States
UCSF Center for Reproductive Health
San Francisco, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Dr. Charles Miller and Associates
Park Ridge, Illinois, United States
Cypress Medical Research Center
Wichita, Kansas, United States
Newton Wellesley Hospital
Newton, Massachusetts, United States
Boston IVF
Waltham, Massachusetts, United States
Maimonides Medical Center
Brooklyn, New York, United States
Duke Universtiy Health System
Morrisville, North Carolina, United States
University Hospitals Landerbrook
Mayfield Heights, Ohio, United States
Prisma Health, Greensville Memorial Hospital
Greenville, South Carolina, United States
The University of Texas at Austin Dept of Womens' Health
Austin, Texas, United States
Texas Fertility Center
Austin, Texas, United States
Aspire Houston Fertility Institute
Houston, Texas, United States
Generations Fertility Care
Middleton, Wisconsin, United States