Juveena Hydrogel System Pivotal Study
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
HEALTHY PARTICIPANTS: No
CONDITION: Surgery for fibroids, Asherman Syndrome
LOCATION: University Hospitals Medical Centers
The purpose of this study is to evaluate whether filling the uterus with a soft gel-like material (“Juveena Hydrogel”) at the end of your gynecological surgical procedure can safely and effectively reduce the development of adhesions. The gel dissolves and will not need to be removed at another time.
Who Can Participate
Premenopausal women 18 years of age or older with a hysteroscopic diagnosis of moderate to severe intrauterine adhesions (Asherman Syndrome), or patients undergoing surgery for fibroids may be eligible for this study.
- STUDY ID# 20222824