Are you a candidate for the BIB System (Gastric Balloon) clinical trial study?

Dear potential study candidate,

Thank you for inquiring about our new clinical research study.  Our study is titled “The BIB Study”  This a study measuring the effects of weight loss when combined with either a temporary stomach balloon device and a wellness program or a 12 month comprehensive wellness program alone.  The study is designed to appoint candidates in one of two pathways with or without a balloon device.  All candidates will participate in a wellness program for 12 months involving nutrition, fitness and behavior support regardless if they have a balloon implanted or not.  Study patients who receive the balloon will have the balloon in their stomach for a duration of six months and then will follow up in the wellness center for the remaining 6 months working on diet and exercise.  Click here to see a visual of the device as well as a schedule of mandatory appointments.  The study does have some compensation for each appointment but does require a signed commitment that shows intent to comply with the study guidelines.

Study candidates must:

1. Be between the ages of 18-65 years of age.
2. BMI of > 30 and <40 Check your BMI here.
3. Have a history of obesity ( BMI > 30kg/m2) for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavioral modification programs;
4. Be willing to commit to a long-term low calorie (1000-1500)calories/day) supervised diet;
5. Have reasonable weight loss expectations (accept a goal of losing up to 15 % of body weight after 26 weeks);
6. 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;
7. Must be willing to take prescribed proton pump inhibitors (PPIs);
8. Be able to provide written informed consent;
9. Be able to provide written Authorization for Use and Release of Health and Research Study Information;
10. Have successful completion of the pre-placement screening, education programs, and psychological assessment supporting that the subject is an appropriate study candidate;
11. Be willing to use contraception (e.g., birth control pills, condoms, abstinence) and avoid pregnancy during the study if female of child-bearing potential.