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COMPLETED
NCT05394662
PHASE3

Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions

Sponsor: Rejoni Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

Juveena Hydrogel System

Application of a novel hydrogel immediately following the transcervical procedure

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