Obesity
Conditions
Brief summary
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Detailed description
The Obalon PAS is a 1-year study that includes 6-month of Obalon Balloon therapy in conjunction of a weight loss behavior modification (WLBM) program and 6-month of continued WLBM program after balloon removal
Interventions
DEVICEObalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
Sponsors
Obalon Therapeutics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 22 years old * BMI of 30-40 kg/m2
Exclusion criteria
* Contraindicated for the device * Use of medications or medical devices known to induce weight gain or weight loss within the preceding 6 months. * Known history of endocrine disorders affecting weight. * Participation in any clinical study which could affect weight loss within the past year * Known history or present condition of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract, including, Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, diverticula, or any other disorder of the esophagus * Life expectancy less than 1 year or severe renal, hepatic, pulmonary or other medical condition, in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Event | 6-Month | Device or Procedure related Serious Adverse Event |
| Percentage of Patients with at least 5% TBWL | 6-Month | Percentage of Patients with at least 5% TBWL |
| Mean % TBWL | 6-Month | Mean %TBWL |
Countries
United States
Outcome results
None listed