Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
201 participants
OBSERVATIONAL
2018-06-15
2021-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Obalon Balloon System
Obalon Balloon System with moderate intensity Weight Loss Behavioral Modification Program
Obalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
Interventions
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Obalon Balloon System
Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
Eligibility Criteria
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Inclusion Criteria
* BMI of 30-40 kg/m2
Exclusion Criteria
* 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
22 Years
ALL
Yes
Sponsors
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Obalon Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shelby Sullivan, MD, FACG
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Rachel Moore, MD, FACS, FASMBS
Role: PRINCIPAL_INVESTIGATOR
Surgical Specialist of Louisiana
Locations
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Smart Dimensions Weight Loss
Fountain Valley, California, United States
Davtyan Medical Weight Loss and Wellness
Glendale, California, United States
Lifetime Surgical Weight Loss
Los Gatos, California, United States
SkyLex Health
Santa Monica, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Surgical Specialists of Louisiana
Metairie, Louisiana, United States
New Jersey Bariatric Center
Springfield, New Jersey, 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
Artisan Cosmetic Surgery
Toledo, Ohio, United States
Minimally Invasive Surgical Associates
Dallas, Texas, United States
Snow Bariatic Center
Flower Mound, Texas, United States
Ultimate Bariatrics
Fort Worth, Texas, United States
Bariatric Medical Institute of Texas
San Antonio, Texas, United States
Countries
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Other Identifiers
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PTL-7500-0011
Identifier Type: -
Identifier Source: org_study_id
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