Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions

Intrauterine Adhesion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394662
• Other study ID #: REJ-CT-0003
• Status: Recruiting
• Phase: Phase 3
• Start date: August 11, 2022
• Est. completion date: March 15, 2025

Study information

• Verified date: April 2024
• Source: Rejoni Inc.
• Contact: Ian Feldberg
• Phone: 978-760-1742
• Email: patientinfo[@]juveena.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• Juveena Hydrogel System
Application of a novel hydrogel immediately following the transcervical procedure

Locations

Country	Name	City	State
United States	Texas Fertility Center	Austin	Texas
United States	The University of Texas at Austin Dept of Womens' Health	Austin	Texas
United States	Maimonides Medical Center	Brooklyn	New York
United States	Carolina Women's Research & Wellness Center	Durham	North Carolina
United States	Prisma Health, Greensville Memorial Hospital	Greenville	South Carolina
United States	Aspire Houston Fertility Institute	Houston	Texas
United States	University Hospitals Landerbrook	Mayfield Heights	Ohio
United States	Generations Fertility Care	Middleton	Wisconsin
United States	Newton Wellesley Hospital	Newton	Massachusetts
United States	Dr. Charles Miller and Associates	Park Ridge	Illinois
United States	Arizona Gynecology Consultants	Phoenix	Arizona
United States	UCSF Center for Reproductive Health	San Francisco	California
United States	Seattle Reproductive Medicine	Seattle	Washington
United States	Boston IVF	Waltham	Massachusetts
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Cypress Medical Research Center	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Rejoni Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from intrauterine adhesions (IUA)	Incidence of No IUA at second look hysteroscopy (SLH)	8 weeks
Secondary	Severity of IUA	Severity of IUA classified according to March criteria at SLH	8 weeks
Secondary	Freedom of IUA with superiority margin of 5% over control at IUA	Incidence of No IUA with superiority margin of 5% over control	8 weeks