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

This is a prospective, multicenter, randomized controlled subject and evaluator-blinded pivotal study to investigate the safety and effectiveness of the Juveena Hydrogel System when used to reduce the occurrence of IUA in women undergoing TCGPs associated with a high prevalence of post-procedural IUA (i.e., adhesiolysis for moderate to severe adhesions or myomectomy of multiple or large myoma). A second look hysteroscopy (SLH) will be performed at the Week 8 visit to evaluate the presence and severity of IUA.

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.
• Use of systemic corticosteroids within 1 week of study procedure.
• Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
• Known allergy to FD&C No.1 dye or polyethylene glycol (PEG).
• Known clotting defects or bleeding disorders.
• Any other general health or mental condition that in the opinion of the investigator could represent an increased risk for the subject, affect the primary outcomes of this study and/or impact the subject's ability to comply with protocol requirements.
• Participating or considering participation in a clinical trial of another investigational drug or device during this study.