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

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

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.

Study Overview

• Status: Completed
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Device: Juveena Hydrogel System; Procedure: Transcervical Gynecologic Procedures (TCGP)

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Arizona Gynecology Consultants
  • California
    • San Francisco, California, United States, 94158
      • UCSF Center for Reproductive Health
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Dr. Charles Miller and Associates
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Massachusetts
    • Newton, Massachusetts, United States, 02462
      • Newton Wellesley Hospital
    • Waltham, Massachusetts, United States, 02451
      • Boston IVF
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • Duke Universtiy Health System
  • Ohio
    • Mayfield Heights, Ohio, United States, 41124
      • University Hospitals Landerbrook
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health, Greensville Memorial Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Fertility Center
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin Dept of Womens' Health
    • Houston, Texas, United States, 77063
      • Aspire Houston Fertility Institute
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Generations Fertility Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcervical Gynecological Procedure + Juveena Hydrogel	Device: Juveena Hydrogel System; Application of a novel hydrogel immediately following the transcervical procedure; Procedure: Transcervical Gynecologic Procedures (TCGP); Hysteroscopic adhesiolysis or hysteroscopic myomectomy
Active Comparator: Transcervical Gynecological Procedure alone (standard of care)	Procedure: Transcervical Gynecologic Procedures (TCGP); Hysteroscopic adhesiolysis or hysteroscopic myomectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rejoni Inc.
• Investigators: Study Director: Ian Feldberg, Rejoni Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): April 23, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Gynatresia
• Other Study ID Numbers: REJ-CT-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No