by Lynn Shapiro
, Writer | February 25, 2009
PR Newswire-- Adam B. Smith, a surgeon in Fort Worth, TX, has been chosen by Allergan Medical for "A Research Study of BioEnterics (Intragastric Balloon or BIB) to assist in the Weight Management of Obese Subjects," a clinical trial to determine the safety and effectiveness of BIB, an inflatable balloon inserted into the stomach, in conjunction with a behavior modification program compared to behavior modification alone for weight loss.
Dr. Smith has been an advanced laparoscopic surgeon for 13 years, and in 2002 he started performing laparoscopic bariatric surgery. After seeing the great success of his patients, Dr. Smith chose the LAP-BAND device for himself. In 2004, he opened Fort Worth LAP-BAND, a private practice dedicated to the treatment of morbid obesity.
According to the Centers for Disease Control, 60 percent of Americans are overweight and nearly 30 percent have a body mass index of 30 or above. Texas ranks as one of the top five "heaviest" states in the nation.
"The investigational device could provide a much-anticipated opportunity for Americans ineligible for adjustable gastric banding procedures because they do not have a body mass index of 35 or above," Smith said. "It is a tool that could offer an advantage to obese individuals who have been excluded for years because they don't meet that magic number but who have a desire to lose the weight."
Participants in the study are men and women between the ages of 18 and 65 years with a body mass index of between 30 and 40 and have at least a two-year history of obesity without success in attempting more conservative weight-reduction alternatives.
According to Smith, subjects will all participate in a holistic weight management program involving a 1,000-1,500 calorie diet. He will place the balloon in 50 percent of the patients, chosen at random, to measure its safety and effectiveness when compared to the control group.
"Because the BIB system is designed to make compliance with a supervised diet and behavior modification program easier, LAP-BAND is well-suited for the BIB system because we have experience in providing comprehensive care to patients who will be required to meet regularly with a dietician, counselor and exercise physiologist in addition to appropriate medical follow up," Smith said.