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

December 11, 2023 updated by: Rejoni Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcervical Gynecological Procedure + Juveena Hydrogel
Device: Juveena Hydrogel System
Application of a novel hydrogel immediately following the transcervical procedure
No Intervention: Transcervical Gynecological Procedure alone (standard of care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from intrauterine adhesions (IUA)
Time Frame: 8 weeks
Incidence of No IUA at second look hysteroscopy (SLH)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of IUA
Time Frame: 8 weeks
Severity of IUA classified according to March criteria at SLH
8 weeks
Freedom of IUA with superiority margin of 5% over control at IUA
Time Frame: 8 weeks
Incidence of No IUA with superiority margin of 5% over control
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rejoni Inc.

Investigators

  • Study Director: Ian Feldberg, Rejoni Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REJ-CT-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intrauterine Adhesion

Clinical Trials on Juveena Hydrogel System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe