~41 spots leftby Apr 2026

Juveena Hydrogel System for Asherman's Syndrome

Recruiting at 15 trial locations
IF
AF
JB
Overseen ByJonathan Bissett
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Rejoni Inc.
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if Juveena hydrogel can safely and effectively reduce scar tissue formation in women who have had certain types of uterine surgeries. The gel is applied inside the uterus to prevent the walls from sticking together during healing.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use systemic corticosteroids within 1 week of the study procedure or have long-acting injectable hormones that would still be active at the time of the procedure.

What data supports the idea that Juveena Hydrogel System for Asherman's Syndrome is an effective treatment?

The available research shows that hyaluronic acid gel, which is similar to Juveena Hydrogel, is effective in preventing the reformation of adhesions after surgery for Asherman's Syndrome. This suggests that Juveena Hydrogel could also be effective in treating the condition. Compared to other treatments like intrauterine balloons and contraceptive devices, hyaluronic acid gel has been shown to be beneficial in preventing adhesions, which supports the effectiveness of Juveena Hydrogel.12345

What safety data is available for the Juveena Hydrogel System for Asherman's Syndrome?

The provided research does not contain any specific safety data for the Juveena Hydrogel System or its variants. The studies focus on other medical devices and treatments, such as vaginal mesh implants, levonorgestrel intrauterine systems, and vaginal energy-based devices, none of which are related to the Juveena Hydrogel System.678910

Is the Juveena Hydrogel System a promising treatment for Asherman's Syndrome?

Yes, the Juveena Hydrogel System is a promising treatment for Asherman's Syndrome. It uses hydrogels, which are special gels that can deliver healing substances directly to the damaged area in the uterus. This helps in repairing the tissue and improving fertility. The system can also release these substances slowly over time, making the treatment more effective.311121314

Research Team

IF

Ian Feldberg

Principal Investigator

Rejoni Inc.

Eligibility Criteria

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.

Inclusion Criteria

Subject agrees to all protocol requirements including returning for specified visits within intervals identified within this protocol.
I agree not to use hormonal birth control or IUDs until after Week 8 of the study.
Subject has signed the IRB/EC approved informed consent
See 4 more

Exclusion Criteria

I have had surgery inside my uterus within the last 2 months.
Pregnant (positive pregnancy test) or lactating.
I have not taken any corticosteroids in the last week.
See 11 more

Treatment Details

Interventions

  • Juveena Hydrogel System (Hydrogel System)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Rejoni Inc.

Lead Sponsor

Trials
3
Recruited
190+

Findings from Research

Asherman's syndrome, a condition caused by intrauterine adhesions, often requires repeated surgeries due to high rates of adhesion recurrence, highlighting the importance of secondary prevention strategies.
Current secondary prevention methods, including second-look hysteroscopy, hormonal treatments, and barrier techniques, show varying efficacy, but combining barriers with hormonal support for endometrial regeneration appears to be the most promising approach.
Prevention of de novo adhesion formation in patients with Asherman's syndrome.BarboraBoudová, Barbora., Lisá, Zdeňka., Richtárová, Adéla., et al.[2021]
Intrauterine infusion of autologous platelet-rich plasma (PRP) was well tolerated by patients with moderate-severe Asherman syndrome (AS), showing no adverse effects during the procedure.
However, the study found no significant improvements in endometrial thickness or pregnancy rates when comparing PRP infusion to saline control, indicating that while PRP is a safe option, its efficacy in enhancing fertility outcomes in AS patients remains uncertain.
Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience.Aghajanova, L., Sundaram, V., Kao, CN., et al.[2022]
In a study of 107 women with Asherman's syndrome, both the intrauterine balloon and intrauterine contraceptive device (IUD) significantly reduced adhesion reformation after hysteroscopic adhesiolysis compared to hyaluronic acid gel and control groups.
The intrauterine balloon was found to be more effective than the IUD in preventing adhesion reformation, highlighting the superiority of mechanical methods over the gel treatment.
A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study.Lin, X., Wei, M., Li, TC., et al.[2022]

References

1.Czech Republicpubmed.ncbi.nlm.nih.gov
Prevention of de novo adhesion formation in patients with Asherman's syndrome. [2021]
Autologous platelet-rich plasma treatment for moderate-severe Asherman syndrome: the first experience. [2022]
A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. [2022]
Treatment of Asherman's syndrome in an outpatient hysteroscopy setting. [2022]
Auto-Cross-Linked Hyaluronic Acid Gel for Prevention of Intrauterine Adhesions after Hysteroscopic Adhesiolysis: A Randomized Controlled Trial. [2021]
User testing a patient information resource about potential complications of vaginally inserted synthetic mesh. [2021]
Acceptability of the levonorgestrel intrauterine system in the long-term treatment of heavy menstrual bleeding: how many women choose to use a second device? [2013]
Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification. [2015]
Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]
Bioengineered endometrial hydrogels with growth factors promote tissue regeneration and restore fertility in murine models. [2021]
Hydrogel, a novel therapeutic and delivery strategy, in the treatment of intrauterine adhesions. [2022]
Three-dimensional structure micelles of heparin-poloxamer improve the therapeutic effect of 17β-estradiol on endometrial regeneration for intrauterine adhesions in a rat model. [2018]
Hyaluronic Acid Hydrogel Integrated with Mesenchymal Stem Cell-Secretome to Treat Endometrial Injury in a Rat Model of Asherman's Syndrome. [2023]