Intergastric Balloon Weight Loss Clinical Trial

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.

The study does have some compensation for each appointment but does require a signed commitment that shows intent to comply with the study guidelines. We will officially be accepting applications for the study starting in January 2010. The applications will be available on the website; www.pugetsoundsurgicalcenter.com

For preliminary information please read the criteria list below; Study candidates must;

1) Be between the ages of 18-65 years of age.
2) BMI of >30 and <40
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.

Schedule of appointments: Participants randomized into the balloon part of the study appointments; Day 1, weeks 1, 2, 4, 8, 12, 16, 20, 26 (BIB® removal), 28, 30, 32, 34, 36, 39, 42, 44, 46, 48, 50, and 52. During these visits, your study doctor will ask you a number of questions, assess your vital signs, have your height and weight measured to calculate your BMI. Your blood (about 4 teaspoons) will be taken from a vein in your arm for regular laboratory tests. Your medications, adverse events, and nutritional and exercise plans will be reviewed.

Participants randomized into the wellness program part of the study appointments; If you are randomized to the Control group, the balloon will not be placed in your stomach. You will complete the behavioral modification program and be on a long-term low calorie (1000-1500 calories/day) supervised diet and on an exercise plan for 52 weeks. At each scheduled study visit your study doctor will measure your height and weight to calculate your BMI. You will have a physical exam and your waist and hip circumference will be measured. Your blood (about 4 teaspoons) will be taken from a vein in your arm for regular laboratory tests. You will also have any necessary tests that need to be repeated if the tests were abnormal or if your study doctor would like to repeat any tests. You will also be asked to complete some questionnaires that ask about quality of life, physical function, eating habits and your feelings.

Interested parties must apply through the website. www.pugetsoundsurgicalcenter.com Inquiries will be pointed to the website for additional information.