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
- Sex at Birth: Female
- Age: Adult (18 - 64)
- Accepting Healthy People: No
- Type: Interventional / Device
- Trial Phase: NA
- Conditions Being Studied:
Study Purpose
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.
Locations
UH Ahuja Medical Center
3999 Richmond Road
Beachwood OH, 44122
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: STUDY20230125
- StudyID: 2022-01092
- ClinicalTrials.gov: NCT05394662
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