Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
NCT ID: NCT05394662
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2022-08-11
2025-04-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion
NCT02220621
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
NCT03353909
New Cross-linked Hyaluronan Gel to Prevent Adhesion After USG-MVA: RCT
NCT05360186
Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
NCT02868437
The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception
NCT05085067
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transcervical Gynecological Procedure + Juveena Hydrogel
Transcervical Gynecological Procedure + Juveena Hydrogel
Juveena Hydrogel System
Application of a novel hydrogel immediately following the transcervical procedure
Transcervical Gynecological Procedure alone (standard of care)
Transcervical Gynecological Procedure alone (standard of care)
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Juveena Hydrogel System
Application of a novel hydrogel immediately following the transcervical procedure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rejoni Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ian Feldberg
Role: STUDY_DIRECTOR
Rejoni Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Gynecology Consultants
Phoenix, Arizona, United States
UCSF Center for Reproductive Health
San Francisco, California, United States
MedStar Washington Hospital Center
Washington D.C., 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REJ-CT-0003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.