BIB for the treatment of obesity - Mark Fusco MD

BIB® research study (Bioenteric Intragastric Balloon)
Please Note: The BIB system has been used to facilitate weight loss in several countries outside of the United States. The BIB is not approved for use in the United States by the Food and Drug Administration (FDA). This web page is strictly for informational purposes only.
Background information
The BIB study is a voluntary research study to evaluate the safety and effectiveness of Allergan's BioEnterics® Intragastric Balloon (BIB)® for the treatment of excess weight. Follow this link for a description of the BIB. The study is sponsored by Allergan Medical.
Purpose of the Study
The reason for this study is to find out about the safety and the effectiveness of the BIB in helping people lose weight. As part of the study Dr. Fusco and his team will provide all study patients with a diet and exercise plan that will be closely monitored over the course of the one year study. Patients will randomly be selected (like flipping a coin) to be in one of two treatment groups. Slightly over half will be in the group that receives a BIB devise in addition to the medically supervised weight loss program. The rest will receive the medically supervise weight loss program alone.
Duration of Study
There is a screening period that can last up to 60 days where study patients are evaluated to confirm they fit the entry criteria for the study. Those patients that qualify then are randomized into one of the two treatment groups. The group receiving the BIB devise has the BIB placed under sedation at the Melbourne GI Center. Both groups at that point start the dietary and exercise program. Both groups will be provided one on one personal trainer visits twice per week, and on going follow up evaluation by our dietitian roughly every two weeks. The BIB devise is removed after six months but the medical weight loss program continues for the full one year in both groups. There are approximately 26 study related visits in the year. Patients are reimbursed for travel expenses for these visits. $25 per visit.
Inclusion Criteria (must be true to participate)
To take part in the study, you must have tried to lose weight before. You must have not been unable to lose weight and keep it off in a weight loss program like diet and exercise. You must want to lose weight and be willing to take part in this study. Losing weight and keeping it off is not easy. You will have to make and maintain major changes in your eating and exercise habits. Additionally, if you are of child-bearing potential you must use a method of control during the study, such as birth control pills, condoms, or abstinence. You can take part in this study if you have a Body Mass Index (BMI) greater than or equal to 30 and less than 40. Follow this link to see if you fall in this range of BMI.
Additional Inclusion Criteria (must be true to participate)
Have a BMI ≥ 30 and ≤ 40; Be male or female, between 18 and 65 years of age, inclusive; Have a history of obesity (BMI ≥ 30 kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs; Be willing to commit to a long-term low calorie (1000-1500 calories/day) supervised diet; Have reasonable weight loss expectations (accept a goal of losing up to 15% of body weight after 26 weeks); Be able to follow requirements outlined in the protocol, including complying with the visit schedule and behavioral modification program, and willing to undergo protocol-specific procedures, e.g., endoscopy, local sedation, general anesthesia, upper gastrointestinal radiography (UGI), electrocardiography (EKG), gastric motility testing, and/or clinical laboratory testing; Must be willing to take prescribed proton pump inhibitors (PPIs); Be able to provide written informed consent; Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.
Exclusion Criteria (must be false to participate)
History of gastrointestinal (GI) surgery (excluding uncomplicated appendectomy or cholecystectomy - gallbladder surgery) History of bowel obstruction, adhesive peritonitis, and/or hiatal hernia (> 2 cm); History of a patulous pyloric channel History or symptoms of esophageal or GI motility disorders A history of myocardial infarction in the previous 6 months: New York Heart Associate (NYHA) Class III or IV (heart failure) or cardiac arrhythmia (e.g., atrial fibrillation); Anemia; History or symptoms of varices, bowel obstruction, congenital or acquired GI anomalies (e.g., atresias, stenosis, stricture, and/or diverticula), severe renal, hepatic, and/or pulmonary disease; History or symptoms of inflammatory bowel disease, such as Crohn's disease; History or symptoms of uncontrolled or unstable thyroid disease; Subjects with a positive test for Helicobacter pylori at screening; History or symptoms in the past 24 months of significant irritable bowel disease, peritonitis, active esophagitis, gastric or duodenal ulceration, GI hemorrhage, or GI bleeding; Type I diabetes; (Type 2 or "Adult Onset Diabetes" is acceptable for enrollment) Placement of previous intragastric balloon or similar device; Ongoing treatment with anticoagulants, steroids, aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), or other medications known to be gastric irritants or to reduce GI motility, and unwillingness to discontinue the use of these concomitant medications; Concomitant use of prescription, non-prescription, or over-the-counter weight loss medications or supplements at any time during the study; Evidence of untreated psychiatric or eating disorders, such as major depression, schizophrenia, substance abuse, binge eating disorder, or bulimia; Pregnancy, breast feeding, or intention of becoming pregnant during the study (if female of childbearing potential)

Additional Information

Calculate your BMI (Body Mass index) Government website that tracks clniical research protocols www.LifeShape.net - Dr. Fusco is the Medical Director of LifeShape Advanced Bariatrics Center of Florida. All obesity surgery is done only through LifeShape.
		LifeShape can be reached at: 321-728-7553

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Not meant as a substitute for consultation with your doctor. Please read disclaimer.