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Juveena Hydrogel System for Asherman's Syndrome

Phase 3
Recruiting
Research Sponsored by Rejoni Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trialtests if a gel can reduce the risk and effects of IUA after a hysteroscopic procedure.

Who is the study for?
This trial is for premenopausal women at high risk of developing intrauterine adhesions, such as those needing hysteroscopic procedures like adhesiolysis or myomectomy. Participants must agree to avoid hormonal contraception and IUDs, not be pregnant or breastfeeding, have no history of certain cancers or infections, and commit to study requirements.Check my eligibility
What is being tested?
The study tests if the Juveena Hydrogel System can prevent scarring inside the uterus after a procedure that could cause these adhesions. Women will either receive this new hydrogel treatment along with their surgery (TCGP + Juveena) or just the surgery alone to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include allergic reactions to ingredients in the hydrogel (like FD&C No.1 dye or polyethylene glycol), infection due to introducing substances into the uterus, and general discomfort from the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have not gone through menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from intrauterine adhesions (IUA)
Secondary outcome measures
Freedom of IUA with superiority margin of 5% over control at IUA
Severity of IUA

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transcervical Gynecological Procedure + Juveena HydrogelExperimental Treatment1 Intervention
Transcervical Gynecological Procedure + Juveena Hydrogel
Group II: Transcervical Gynecological Procedure alone (standard of care)Active Control1 Intervention
Transcervical Gynecological Procedure alone (standard of care)

Find a Location

Who is running the clinical trial?

Rejoni Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Ian FeldbergStudy DirectorRejoni Inc.

Media Library

Transcervical Gynecological Procedure + Juveena Hydrogel Clinical Trial Eligibility Overview. Trial Name: NCT05394662 — Phase 3
Asherman's Syndrome Research Study Groups: Transcervical Gynecological Procedure alone (standard of care), Transcervical Gynecological Procedure + Juveena Hydrogel
Asherman's Syndrome Clinical Trial 2023: Transcervical Gynecological Procedure + Juveena Hydrogel Highlights & Side Effects. Trial Name: NCT05394662 — Phase 3
Transcervical Gynecological Procedure + Juveena Hydrogel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05394662 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization for Transcervical Gynecological Procedure + Juveena Hydrogel?

"Generated evidence and multiple studies have established the safety of Transcervical Gynecological Procedure + Juveena Hydrogel, thus assigning it a grade 3 on our rating scale."

Answered by AI

How many locales are managing this experiment?

"This clinical trial is being conducted by Dr. Charles Miller and Associates in Park Ridge, Illinois, Cypress Medical Research Center in Wichita, Kansas, Maimonides Medical Center in Brooklyn New york as well as an additional 7 hospitals nationwide."

Answered by AI

How many participants are being sought for the experiment?

"150 willing participants who meet the outlined criteria are necessary for this study. These volunteers can join from either Dr. Charles Miller and Associates in Park Ridge, Illinois or Cypress Medical Research Center in Wichita, Kansas."

Answered by AI

Are any slots still open for participants in this research?

"Affirmative. The clinicaltrials.gov website suggests that the trial is presently recruiting participants, which was originally announced on August 11th 2022 and last updated on January 5th 2023. 150 patients are needed from 7 medical facilities for this project to be successful."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Texas at Austin Dept of Womens' Health
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have had 3 cancelled FETs due to thin lining (3 mm) and have undergone 4 hysteroscopies due to scarring and Asherman’s syndrome. I just tried PRP treatment and went through a FET at 4.9 mm that ended in chemical pregnancy. I would like to to try a different treatment to aid with future FETs.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions
2022. "Safety and Effectiveness of Juveena™ Hydrogel System Following TCGP At High-Risk for Intrauterine Adhesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394662.
~56 spots leftby Apr 2025
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