Clinical trial NCT00730327: A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
Official title: Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Apollo Endosurgery, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Safety and effectiveness of the BIB® System in conjunction with a behavior modification program compared to the behavior modification program alone for weight loss in obese subjects.


Eligibility criteria: 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)

Primary outcomes:
measure: Mean Percent Excess Weight Loss (%EWL)
timeFrame: 9 months
measure: Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group
timeFrame: 9 months
Secondary outcomes:
measure: Percent of Participants With Comorbid Conditions
timeFrame: Baseline, Week 26, Week 39, Week 52
measure: Change in Quality of Life (SF-36)
timeFrame: Baseline, Week 39
measure: Change in Quality of Life (IWQOL-Lite)
timeFrame: Baseline, Week 26, Week 39, Week 52
measure: Change in Participant Depression (Beck Depression Inventory II)
timeFrame: Baseline, Week 26, Week 39, Week 52
Other outcomes:
Locations:
city: Austin
country: United States
facility: Apollo Endosurgery
state: Texas
Study officials:
affiliation: Apollo Endosurgery, Inc.
name: Laura Eaton, RN, BSN
role: STUDY_DIRECTOR
References:
citation: Gomez V, Woodman G, Abu Dayyeh BK. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: Results of a prospective study. Obesity (Silver Spring). 2016 Sep;24(9):1849-53. doi: 10.1002/oby.21555. Epub 2016 Jul 28.