At a glance
ClinicalIndex Comparison RecordN/ACompleted· 448 enrolled
Drug / intervention
BioEnterics® Intragastric Balloon +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of the BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects
In Brief
A clinical study evaluating BioEnterics® Intragastric Balloon and Behavioral modification for Obesity. Completed, enrolled 448 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedAug 2008
Primary CompletionOct 2011
TodayJul 2026
First PostedAug 8, 2008
Enrollment StartJun 1, 2008
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.9 years ago
Interventions
BioEnterics® Intragastric Balloondevice
Inflatable balloon inserted into the stomach.
Behavioral modificationother
Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise