Status:
COMPLETED
Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
Lead Sponsor:
Rejoni Inc.
Conditions:
Intrauterine Adhesion
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 se...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05394662
Start Date
August 11 2022
End Date
April 23 2025
Last Update
May 23 2025
Active Locations (15)
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1
Arizona Gynecology Consultants
Phoenix, Arizona, United States, 85020
2
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158
3
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Dr. Charles Miller and Associates
Park Ridge, Illinois, United States, 60068