InSightec Granted Clearance for ExAblate Fertility Study
Posted on: Thursday, 29 May 2008, 09:01 CDT
InSightec has received the FDA clearance to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate 2000 system utilizing MR-guided focused ultrasound surgery for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.
A total of 20 US and international sites will enroll 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.
Kobi Vortman, president and CEO of InSightec, said: "We remain highly committed to moving the treatment paradigm away from invasive surgeries. To date, over 4,000 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery. Should this trial confirm our expectations, more women will be able to choose a non-invasive treatment."
Source: Datamonitor
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