FDA Clears ExAblate Fertility Enhancement Study
May 28, 2008 - InSightec Ltd. announced today that the FDA cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.
Twenty U.S. and international sites will enroll a total of 650 women with uterine fibroids who are diagnosed with unexplained infertility. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed.
The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment.
Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.
For more information: www.insightec.com
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