Contact:Sandra Burks
Phone:(434)243-0315
E-mail:sgb2c@virginia.edu
UVa Health System, the Departments of Radiology and Obstetrics and Gynecology, seek Healthy Women ages 21-40 experiencing infertility, for a research study.
The purpose of this research study is to evaluate whether the Investigational Device ExAblate is safe and helpful in the treatment of uterine fibroids for fertility enhancement (improving chances of becoming pregnant), as compared to surgical removal of the fibroids, called myomectomy.
Women who participate in the study will be monitored to see if they are able to become pregnant. The study will test the safety of the ExAblate device by monitoring any complications related to the study procedure, all pregnancies, any delivery-related complications, and any complications to the baby from the point just after receiving the first treatment through 60 months post-treatment. If you become pregnant, your progress will be followed through the birth of your baby, which could be as long as 9 months after the 60-month visit. Information about your pregnancy and delivery will be collected and shared with the sponsor of this study, InSightec, Inc.
In addition to collecting information on any pregnancies, this study will include some questionnaires and surveys that will ask about your symptoms, general medical condition, emotional health, and health care expenses. The study also includes physical examinations, imaging studies to help look at the helpfulness of the ExAblate procedure. .
No compensation is provided for this study.
Contact Information:
For more information please contact:
Study nurse coordinators in the Surgical Therapeutic Advancement Center
Office: 434-243-0315
Email: uvastac@virginia.edu
IRB-HSR # 14556
Principal Investigator: Dr. Alan Matsumoto
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Primary Investigator: Matsumoto Alan, H