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New gel may stop uterine scars after surgery

NCT ID NCT05394662

Disease control Sponsor: Rejoni Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special gel called Juveena in 150 women who had certain gynecologic procedures that put them at high risk for developing scar tissue inside the uterus. The gel is placed into the uterus right after the procedure to see if it can safely reduce the formation and severity of these scars. The main goal was to check if the gel helped keep the uterus free of adhesions when looked at with a camera 8 weeks later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

150 people

The number who actually took part.

Started

Aug 2022

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Asherman syndrome gynatresia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrauterine adhesion

Contacts and locations

Locations

  • Arizona Gynecology Consultants

    Phoenix, Arizona, 85020, United States

  • Aspire Houston Fertility Institute

    Houston, Texas, 77063, United States

  • Boston IVF

    Waltham, Massachusetts, 02451, United States

  • Cypress Medical Research Center

    Wichita, Kansas, 67226, United States

  • Dr. Charles Miller and Associates

    Park Ridge, Illinois, 60068, United States

  • Duke Universtiy Health System

    Morrisville, North Carolina, 27560, United States

  • Generations Fertility Care

    Middleton, Wisconsin, 53562, United States

  • Maimonides Medical Center

    Brooklyn, New York, 11219, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Newton Wellesley Hospital

    Newton, Massachusetts, 02462, United States

  • Prisma Health, Greensville Memorial Hospital

    Greenville, South Carolina, 29605, United States

  • Texas Fertility Center

    Austin, Texas, 78731, United States

  • The University of Texas at Austin Dept of Womens' Health

    Austin, Texas, 78712, United States

  • UCSF Center for Reproductive Health

    San Francisco, California, 94158, United States

  • University Hospitals Landerbrook

    Mayfield Heights, Ohio, 41124, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.