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| Sponsor: | Allergan Medical |
|---|---|
| Information provided by: | Allergan Medical |
| ClinicalTrials.gov Identifier: | NCT00730327 |
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: | Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects |
| Estimated Enrollment: | 538 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
BIB®
|
Device: BioEnterics® Intragastric Balloon
Inflatable balloon inserted into stomach
|
|
2
Control
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allergan Medical | devicetrials@allergan.com |
| United States, California | |
| Recruiting | |
| Santa Barbara, California, United States | |
More Information
| Responsible Party: | Allergan Medical ( Allergan Medical ) |
| Study ID Numbers: | IB-005 |
| Study First Received: | August 6, 2008 |
| Last Updated: | December 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00730327 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |