SAN RAMON, Calif., Aug. 24 /PRNewswire/ — 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 (wi