Clinical trial NCT05394662: Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intrauterine Adhesion
Lead sponsor: Rejoni Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Juveena Hydrogel vs No Hydrogel
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from intrauterine adhesions (IUA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Severity of IUA
timeFrame: 8 weeks
measure: Freedom of IUA with superiority margin of 5% over control at IUA
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Gynecology Consultants
state: Arizona
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Park Ridge
country: United States
facility: Dr. Charles Miller and Associates
state: Illinois
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Morrisville
country: United States
facility: Duke Universtiy Health System
state: North Carolina
city: Mayfield Heights
country: United States
facility: University Hospitals Landerbrook
state: Ohio
city: Greenville
country: United States
facility: Prisma Health, Greensville Memorial Hospital
state: South Carolina
city: Austin
country: United States
facility: The University of Texas at Austin Dept of Womens' Health
state: Texas
city: Austin
country: United States
facility: Texas Fertility Center
state: Texas
city: Houston
country: United States
facility: Aspire Houston Fertility Institute
state: Texas
city: Middleton
country: United States
facility: Generations Fertility Care
state: Wisconsin
Study officials:
affiliation: Rejoni Inc.
name: Ian Feldberg
role: STUDY_DIRECTOR
References: