Commonly referred to as “Asherman's Syndrome”, IUAs are bands of fibrous tissue that form in the uterus, often in response to a uterine procedure. As many as 40% of women who have had some type of surgical procedure inside the uterus develop Asherman's Syndrome. Your doctor can see these adhesions using ultrasound or by putting a thin telescope inside the uterus; a procedure called hysteroscopy.
The thicker the bands of scar tissue, the more they can cause the uterine cavity to narrow, resulting in pain, skipped, sparse or absent menstrual periods as well as recurring pregnancy loss and other pregnancy complications.
Working closely with leading physicians, Rejoni™ is conducting a clinical trial to learn if a soft gel-like material, called Juveena™ Hydrogel may prevent intrauterine adhesions after uterine surgery.
In this study, potential participants are those who are undergoing uterine surgery either to remove fibroids or to disrupt existing adhesions in a procedure called adhesiolysis. Qualified participants will be randomly assigned to either receive instillation of the hydrogel (treatment group) directly after completion of the uterine surgery or to not have the hydrogel instilled (control group). Two women will be assigned to the treatment group for every one assigned to the control group.
If you are at least 18 years old, and your diagnosis through imaging has identified that you should undergo fibroid removal or adhesiolysis, you may be eligible to participate. There is no cost to you to participate in this clinical study.
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These statements have not been evaluated by the Food and Drug Administration. CAUTION – Investigational device. Limited by Federal (USA) Law to investigational use.
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