Obalon Balloon System Post-Approval Study
PAS
Obalon Balloon System - Post-Approval Study
1 other identifier
observational
201
1 country
15
Brief Summary
The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2021
CompletedApril 30, 2020
April 1, 2020
2.2 years
June 15, 2018
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Serious Adverse Event
Device or Procedure related Serious Adverse Event
6-Month
Percentage of Patients with at least 5% TBWL
Percentage of Patients with at least 5% TBWL
6-Month
Mean % TBWL
Mean %TBWL
6-Month
Study Arms (1)
Obalon Balloon System
Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program
Interventions
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
Eligibility Criteria
* Patients aged 22 years and older, who are considered obesity Class I or II with a BMI of 30.0-40.0 kg/m2; and, have failed to lose weight through diet and exercise * Patients willing to commercially purchase the device.
You may qualify if:
- At least 22 years old
- BMI of 30-40 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Smart Dimensions Weight Loss
Fountain Valley, California, 92694, United States
Davtyan Medical Weight Loss and Wellness
Glendale, California, 91202, United States
Lifetime Surgical Weight Loss
Los Gatos, California, 95032, United States
SkyLex Health
Santa Monica, California, 90404, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Surgical Specialists of Louisiana
Metairie, Louisiana, 70001, United States
New Jersey Bariatric Center
Springfield, New Jersey, 07081, United States
Greenwich Village Gastroenterology
Poughkeepsie, New York, 12601, United States
New York Bariatric Group
Roslyn Heights, New York, 11577, United States
JourneyLite Physicians
Cincinnati, Ohio, 45241, United States
Artisan Cosmetic Surgery
Toledo, Ohio, 43617, United States
Minimally Invasive Surgical Associates
Dallas, Texas, 75208, United States
Snow Bariatic Center
Flower Mound, Texas, 75028, United States
Ultimate Bariatrics
Fort Worth, Texas, 76102, United States
Bariatric Medical Institute of Texas
San Antonio, Texas, 78258, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shelby Sullivan, MD, FACG
University of Colorado, Denver
- PRINCIPAL INVESTIGATOR
Rachel Moore, MD, FACS, FASMBS
Surgical Specialist of Louisiana
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2018
First Posted
June 26, 2018
Study Start
June 15, 2018
Primary Completion
September 13, 2020
Study Completion
March 13, 2021
Last Updated
April 30, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share