A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Inclusion Criteria:

- 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)and other medications
as prescribed by the investigator;

- Be able to provide written informed consent and authorization for use and release of
Health and Research Study Information;

- 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:

- Any surgery of the foregut excluding uncomplicated cholecystectomy

- History or symptoms of gastrointestinal (GI) surgery (excluding uncomplicated
appendectomy), GI obstruction, adhesive peritonitis, and/or hiatal hernia (>/= 2 cm);

- A patulous pyloric channel;

- History or symptoms of esophageal or GI motility disorders (not just those with <40%)
as these patients are particularly susceptible to the development of esophagitis;

- History or previous symptoms of delayed Gastric Emptying (GE) and/or delayed GE
having been documented on a previously performed gastric scintigraphy study or
another previously performed diagnostic study such as a UGI x-ray series;

- Current symptoms of delayed GE;

- 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 defined as a hemoglobin value for females of <11.3 g/dl and for males < 13.0
g/dl;

- 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 or
Ulcerative Colitis;

- History or symptoms of uncontrolled or unstable thyroid disease;

- Subjects with a positive test for Helicobacter pylori (H.p.) at screening; subjects
may participate in the study if, prior to randomization, they are treated with a
pharmacological regimen designed to eradicate their H.p. and subsequently have a
negative H.p. breath test indicating that the H.p. has been eradicated

- History or symptoms in the past 24 months of significant irritable bowel syndrome,
peritonitis, active esophagitis, gastritis and/or duodenitis, gastric or duodenal
ulceration, GI hemorrhage, or GI bleeding;

- Type I diabetes;

- 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 gastroduodenal
mucosal irritants or to reduce GI motility, and/or an 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;

- Current enrollment in an investigational drug or device study or participation in
such a study within 30 days of entry into this study;

- Poor general health, presence of a specific condition, or is in a situation, which in
the Evaluating and/or Placing Investigator's opinion may put the subject at
significant risk, may confound the study results, may increase the risks associated
with endoscopy and/or placement of the BIB, or may interfere significantly with the
subject's participation in the study (e.g., HIV, Hepatitis C, or cancer history
within the last 5 years)