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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier:
NCT00730327
First received: August 6, 2008
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Obesity
Device: BioEnterics® Intragastric Balloon
Other: Behavioral modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Resource links provided by NLM:


Further study details as provided by Apollo Endosurgery, Inc.:

Primary Outcome Measures:
  • Safety of the BIB® System as an adjunct to a behavioral modification program for weight management [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effectiveness of the BIB® System [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 449
Study Start Date: June 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIB®
Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention.
Device: BioEnterics® Intragastric Balloon
Inflatable balloon inserted into the stomach.
Other Name: BIB®
Other: Behavioral modification
Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Control
Control arm receives the Behavioral modification intervention only.
Other: Behavioral modification
Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00730327

Locations
United States, Texas
Apollo Endosurgery
Austin, Texas, United States, 78746
Sponsors and Collaborators
Apollo Endosurgery, Inc.
  More Information

No publications provided

Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00730327     History of Changes
Other Study ID Numbers: IB-005
Study First Received: August 6, 2008
Last Updated: May 18, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 02, 2015