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

Phase 3

Completed

• Conditions: Intrauterine Adhesion
• Interventions: Device: Juveena Hydrogel System

• Registration Number: NCT05394662
• Lead Sponsor: Rejoni Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-08-11
• Primary Completion: 2025-04-23
• Study Completion: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Premenopausal

2. Candidate for one of the following hysteroscopic procedures:

   1. Adhesiolysis of moderate to severe adhesions confirmed hysteroscopically
   2. Hysteroscopic Myomectomy confirmed via imaging in subjects with symptomatic disease

3. Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.

4. Subject is willing to undergo an SLH at the Week 8 visit.

5. Subject agrees to abstain from sexual intercourse or use a reliable form of barrier contraception following the study procedure through the Week 8 visit.

6. Subject has signed the IRB/EC approved informed consent

Exclusion Criteria

1. Postmenopausal
2. IUD present at time of TCGP (unless removed before or during procedure)
3. Past history of endometrial cancer or atypical endometrial hyperplasia (endometrial intraepithelial neoplasia).
4. Planned intrauterine interventions post-TCGP through the Week 8 visit.
5. Recent intrauterine surgery within 6 weeks before the planned study procedure.
6. Pregnant (positive pregnancy test) or lactating.
7. 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.
8. 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.
9. Use of systemic corticosteroids within 1 week of study procedure.
10. Treated with long-acting injectable hormone/hormone implant that would still be active at the time of the TCGP.
11. Known allergy to FD&C No.1 dye or polyethylene glycol (PEG).
12. Known clotting defects or bleeding disorders.
13. 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.
14. Participating or considering participation in a clinical trial of another investigational drug or device during this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcervical Gynecological Procedure + Juveena Hydrogel	Juveena Hydrogel System	Transcervical Gynecological Procedure + Juveena Hydrogel

Primary Outcome Measures

Name	Time	Method
Freedom from intrauterine adhesions (IUA)	8 weeks	Incidence of No IUA at second look hysteroscopy (SLH)

Secondary Outcome Measures

Name	Time	Method
Severity of IUA	8 weeks	Severity of IUA classified according to March criteria at SLH
Freedom of IUA with superiority margin of 5% over control at IUA	8 weeks	Incidence of No IUA with superiority margin of 5% over control

Trial Locations

Locations (15)

Arizona Gynecology Consultants; 🇺🇸 Phoenix, Arizona, United States

UCSF Center for Reproductive Health; 🇺🇸 San Francisco, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Dr. Charles Miller and Associates; 🇺🇸 Park Ridge, Illinois, United States

Cypress Medical Research Center; 🇺🇸 Wichita, Kansas, United States

Newton Wellesley Hospital; 🇺🇸 Newton, Massachusetts, United States

Boston IVF; 🇺🇸 Waltham, Massachusetts, United States

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States

Duke Universtiy Health System; 🇺🇸 Morrisville, North Carolina, United States

University Hospitals Landerbrook; 🇺🇸 Mayfield Heights, Ohio, United States

Prisma Health, Greensville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

The University of Texas at Austin Dept of Womens' Health; 🇺🇸 Austin, Texas, United States

Texas Fertility Center; 🇺🇸 Austin, Texas, United States

Aspire Houston Fertility Institute; 🇺🇸 Houston, Texas, United States

Generations Fertility Care; 🇺🇸 Middleton, Wisconsin, United States