The Reproductive Science Center of the San Francisco Bay Area (RSC) is hoping to recruit 150 women suffering from uterine fibroids, benign tumors that can cause extreme pain and infertility.
Fibroids are non-cancerous tumors or growths in the wall of the uterus. The cause of uterine fibroid tumors is unknown. Fifty percent of all women develop these tumors during their lifetime. In fact, uterine fibroids are the most common medical condition for which a hysterectomy is performed (there are 325,000 cases per year in the United States).
Donald I. Galen, M.D., Research Director of RSC, is the principal investigator for this clinical research trial, developed to evaluate the safety and effectiveness of a new minimally invasive surgical procedure at RSC's San Ramon clinic.
A new device manufactured by Northern California-based Halt Medical recently received FDA 510K clearance using a radio-frequency energy system to treat soft tissues. Fully qualified doctors insert the Halt System into targeted fibroids under ultrasound guidance. This procedure targets the core of the fibroid, by cauterizing the blood flow that feeds the fibroid, which decreases fibroid size and subsequent discomfort.
"This device is being studied as a possible treatment option for patients with symptomatic uterine fibroids for use in an outpatient setting with fast recovery. Only small puncture marks, not a large surgical cut, are required," said Galen. "It is a far less invasive procedure with lower risks and costs than hysterectomy."
Participants in this research study will receive a confidential interview, a medical evaluation, a complete medical exam, laboratory testing, diagnostic testing, as well receive the new medical procedure, at no cost. Eligible participants must be between age 25 and up to perimenopausal (with normal cycles) and must not desire future pregnancies.
The screening process takes as long as six weeks. The procedure involves general anesthetic and takes from three to six weeks from initial screening to treatment. A three-year follow up is required. For more information, visit www.rscbayarea.com or call Jennifer McWatters, 925.973.5012.
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