Obalon Balloon System Post-Approval Study
- Conditions
- Obesity
- Interventions
- Device: Obalon Balloon System
- Registration Number
- NCT03570034
- Lead Sponsor
- Obalon Therapeutics, Inc.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 201
- At least 22 years old
- BMI of 30-40 kg/m2
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obalon Balloon System Obalon Balloon System Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Surgical Specialists of Louisiana
🇺🇸Metairie, Louisiana, United States
New Jersey Bariatric Center
🇺🇸Springfield, New Jersey, United States
Davtyan Medical Weight Loss and Wellness
🇺🇸Glendale, California, United States
Smart Dimensions Weight Loss
🇺🇸Fountain Valley, California, United States
Lifetime Surgical Weight Loss
🇺🇸Los Gatos, California, United States
SkyLex Health
🇺🇸Santa Monica, California, United States
Greenwich Village Gastroenterology
🇺🇸Poughkeepsie, New York, United States
New York Bariatric Group
🇺🇸Roslyn Heights, New York, United States
JourneyLite Physicians
🇺🇸Cincinnati, Ohio, United States
Minimally Invasive Surgical Associates
🇺🇸Dallas, Texas, United States
Ultimate Bariatrics
🇺🇸Fort Worth, Texas, United States
Artisan Cosmetic Surgery
🇺🇸Toledo, Ohio, United States
Snow Bariatic Center
🇺🇸Flower Mound, Texas, United States
Bariatric Medical Institute of Texas
🇺🇸San Antonio, Texas, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States