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November 13, 2008
by Susan Frimmel
Services
PRMC and Lee Grossbard, MD Selected for Non-Surgical Weight Loss Procedure and FDA Clinical Trial
Dade City,
Fla. (November 13, 2008) – Pasco Regional Medical Center
announced today that it is one of 15 hospitals in the nation chosen for an FDA
randomized, multi-center study to evaluate the safety and effectiveness of
Allergan’s BioEnterics® Intragastric Balloon (BIB®) System for the treatment of
excess weight.
Lee Grossbard, M.D., award winning
general and bariatric surgeon at Pasco
Regional Medical
Center, is leading this
study. Dr. Grossbard received training
on the BioEnterics® Intragastric Balloon (BIB®) System from expert surgeon, Alfredo Genco, M.D. of Rome, Italy.
Dr. Genco traveled from Italy to Dade City
to further train Dr.Grossbard in this procedure.
The BioEnterics Intragastric
Balloon (BIB®) is designed to help patients lose weight by partially filling
the stomach and creating an early feeling of fullness. The balloon is designed to move freely within
the stomach. It is made of a soft,
smooth, silicone elastomer. After the
balloon is endoscopicly placed in the stomach, the doctor fills it with saline.
The saline solution expands the balloon to a round shape about the size of a
soft ball, weighing approximately one pound.
The balloon is designed to be used only once and can stay in the
patient’s stomach for no longer than 6 months.
There is always the chance a new
and unexpected side effect could occur.
Some of the associated risks include balloon intolerance, balloon
deflation, bowel obstruction, gastric ulcers, esophageal obstruction and esophageal
perforation.
Twenty-four subjects (patients)
have been selected for this study.
During the study, Dr. Grossbard will closely monitor each patient’s
progression. This is a 52 week study and
patients are required to return to the doctor’s office twenty times during the
course of the trial. In addition, study participants will have weekly meetings
with a nutritionist and will attend monthly support group and informational
sessions.
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