Juveena Hydrogel System for Asherman's Syndrome
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
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
Exclusion Criteria
Treatment Details
Interventions
- Juveena Hydrogel System (Hydrogel System)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rejoni Inc.
Lead Sponsor