Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedur… (NCT05394662) | Clinical Trial Compass
CompletedPhase 3
Safety and Effectiveness of Juveenaâ„¢ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions
United States150 participantsStarted 2022-08-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Premenopausal
✓. Candidate for one of the following hysteroscopic procedures:
✓. Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
✓. Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease
✓. Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
✓. Subject is willing to undergo an SLH at the Week 8 visit.
✓. Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.
✓. Subject has signed the IRB/EC approved informed consent
Exclusion criteria
✕. Postmenopausal
✕. IUD present at time of TCGP (unless removed before or during procedure)
✕. Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
✕. Planned intrauterine interventions post-TCGP through the Week 8 visit.
✕. Recent intrauterine surgery within 6 weeks before the planned study procedure.
✕. Pregnant (positive pregnancy test) or lactating.
✕. Pregnancy within the last 6 weeks prior to the planned study procedure for a trimester loss (≤13 weeks gestation) within 3 months of planned study procedure for all other pregnancies.
✕. Active sexually transmitted infection (i.e., positive testing for gonorrhea/chlamydia), or genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis) or other active and/or systemic infection.