The purpose of this study is to learn if filling the uterus with a soft gel-like material (Juveena Hydrogel) at the end of your gynecological surgical procedure can safely and effectively reduce the development of intrauterine adhesions (fibrous scar tissue).
The device is referred to as “hydrogel” as it is made of approximately 90% water. The other main ingredient is polyethylene glycol or “PEG” a material that is widely used in the preparation of drugs and other medical products. The hydrogel material will gradually breakdown over time (within approximately 2-3 weeks) so there is no other procedure needed to remove the gel.
You may be eligible for this study if you are scheduled for a hysteroscopic procedure to remove specific types of fibroids or adhesions and you meet other specific requirements for study participation.
In this study, at least 150 patients are expected to be enrolled with approximately 100 receiving the Juveena Hydrogel system and approximately 50 not receiving it. Whether or not you receive the gel material, the gynecological procedure you will be undergoing will be performed in the same way and using the same equipment as if you were not participating in this study.
You and/or your insurance company will be billed for the costs of the procedures in the study in the hospital and at follow-up visits, which are considered to be normal and standard medical practice for someone undergoing a transcervical gynecological procedure. Tests and procedures required specifically for this study that will not be covered by your medical insurance, will be paid for by Rejoni. As per standard of care, you will need to pay for any copays and medicines you are prescribed for any other medical conditions not related to the study procedures.
You will receive compensation as reimbursement for your time and travel costs associated with completing all research study visits.
For more information about this study, please call 316-425-6333.
