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

NCT00730327 | Completed Results

• 1 other identifier: IB-005
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Mean Percent Excess Weight Loss (%EWL)

  The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.

  9 months

• Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group

  The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) \* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.

  9 months

Secondary Outcomes (4)

• Percent of Participants With Comorbid Conditions

  Baseline, Week 26, Week 39, Week 52

• Change in Quality of Life (SF-36)

  Baseline, Week 39

• Change in Quality of Life (IWQOL-Lite)

  Baseline, Week 26, Week 39, Week 52

• Change in Participant Depression (Beck Depression Inventory II)

  Baseline, Week 26, Week 39, Week 52

Study Arms (2)

BIB®

EXPERIMENTAL

Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.

Device: BioEnterics® Intragastric Balloon; Other: Behavioral modification

Control

OTHER

Control arm receives the Behavioral modification intervention only.

Other: Behavioral modification

Interventions

BioEnterics® Intragastric Balloon DEVICE

Inflatable balloon inserted into the stomach.

Also known as: BIB®

BIB®

Behavioral modification OTHER

Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise

BIB®; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Apollo Endosurgery, Inc.: lead

Study Sites (1)

Apollo Endosurgery

Austin, Texas, 78746, United States

Location

Related Publications (1)

• 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.

  PMID: 27465076 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Laura Eaton, Study Director, RN, BSN, CCRN-R,
• Organization: Apollo Endosurgery

laura.eaton@apolloendo.com

949-468-9301

Study Officials

• Laura Eaton, RN, BSN

  Apollo Endosurgery, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-10

Locations

US (1)