Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
a study on Intrauterine Adhesion
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedcompletion around
Description
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.
Official Title
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
Details
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.
Keywords
Intrauterine Adhesion, Tissue Adhesions, Juveena Hydrogel System, Transcervical Gynecological Procedure + Juveena Hydrogel
Eligibility
You can join if…
Open to females ages 18 years and up
- 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 CAN'T join 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.
Locations
- UCSF Center for Reproductive Health
accepting new patients
San Francisco California 94158 United States - Arizona Gynecology Consultants
accepting new patients
Phoenix Arizona 85020 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Rejoni Inc.
- ID
- NCT05394662
- Phase
- Phase 3 Intrauterine Adhesion Research Study
- Study Type
- Interventional
- Participants
- Expecting 150 study participants
- Last Updated