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

NCT00730327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2015-11-06

Study results available
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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

Interventions

DEVICE

BioEnterics® Intragastric Balloon

Inflatable balloon inserted into the stomach.

OTHER

Behavioral modification

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

Sponsors & Collaborators

  • Apollo Endosurgery, Inc.

    lead INDUSTRY

Principal Investigators

  • Laura Eaton, RN, BSN · Apollo Endosurgery, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730327 on ClinicalTrials.gov