Safety and Effectiveness of Juveena™ Hydrogel System Following Transcervical Gynecologic Procedures (TCGP) At High-Risk for Intrauterine Adhesions
1 other identifier
interventional
150
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2022
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Start
First participant enrolled
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2025
CompletedApril 21, 2026
April 1, 2026
2.7 years
May 24, 2022
April 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from intrauterine adhesions (IUA)
Incidence of No IUA at second look hysteroscopy (SLH)
8 weeks
Secondary Outcomes (2)
Severity of IUA
8 weeks
Freedom of IUA with superiority margin of 5% over control at IUA
8 weeks
Study Arms (2)
Transcervical Gynecological Procedure + Juveena Hydrogel
EXPERIMENTALTranscervical Gynecological Procedure + Juveena Hydrogel
Transcervical Gynecological Procedure alone (standard of care)
ACTIVE COMPARATORTranscervical Gynecological Procedure alone (standard of care)
Interventions
Application of a novel hydrogel immediately following the transcervical procedure
Hysteroscopic adhesiolysis or hysteroscopic myomectomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rejoni Inc.lead
Study Sites (15)
Arizona Gynecology Consultants
Phoenix, Arizona, 85020, United States
UCSF Center for Reproductive Health
San Francisco, California, 94158, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Dr. Charles Miller and Associates
Park Ridge, Illinois, 60068, United States
Cypress Medical Research Center
Wichita, Kansas, 67226, United States
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Boston IVF
Waltham, Massachusetts, 02451, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Duke Universtiy Health System
Morrisville, North Carolina, 27560, United States
University Hospitals Landerbrook
Mayfield Heights, Ohio, 41124, United States
Prisma Health, Greensville Memorial Hospital
Greenville, South Carolina, 29605, United States
The University of Texas at Austin Dept of Womens' Health
Austin, Texas, 78712, United States
Texas Fertility Center
Austin, Texas, 78731, United States
Aspire Houston Fertility Institute
Houston, Texas, 77063, United States
Generations Fertility Care
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ian Feldberg
Rejoni Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Subjects won't be told which group they were assigned. Primary outcome reviewed by blinded independent central review.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
May 27, 2022
Study Start
August 11, 2022
Primary Completion
April 23, 2025
Study Completion
April 23, 2025
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share