Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Device: Juveena Hydrogel System


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Juveena Hydrogel vs No Hydrogel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcervical Gynecological Procedure + Juveena Hydrogel<br>Transcervical Gynecological Procedure + Juveena Hydrogel | Device: Juveena Hydrogel System<br>* Application of a novel hydrogel immediately following the transcervical procedure<br>|
| No Intervention: Transcervical Gynecological Procedure alone (standard of care)<br>Transcervical Gynecological Procedure alone (standard of care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from intrauterine adhesions (IUA) | Incidence of No IUA at second look hysteroscopy (SLH) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of IUA | Severity of IUA classified according to March criteria at SLH | 8 weeks | 
| Freedom of IUA with superiority margin of 5% over control at IUA | Incidence of No IUA with superiority margin of 5% over control | 8 weeks |