Phase
Condition
Obesity
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages > 22 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ages 22 years and older
Starting or current therapy BMI of 30.0-40.0 kg/m2
Commercially purchased the Obalon Balloon Device
Exclusion
Exclusion Criteria:
Known history of structural or functional disorders of the esophagus that may impedepassage of the device through the gastrointestinal tract or increase risk ofesophageal damage during an endoscopic removal procedure, including, Barrett'sesophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices,esophageal diverticula, esophageal perforation or any other disorder of the esophagus.
Known history of structural or functional disorder of the esophagus, including anyswallowing disorder, esophageal chest pain disorders, or drug refractory esophagealreflux symptoms.
Known history of structural or functional disorders of the stomach including,gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2cm), cancer or any other disorder of the stomach.
Active implantable devices, such as a pacemaker of defibrillator, or with metalimplants in the thoracic region.
Study Design
Study Description
Connect with a study center
Ultimate Bariatrics - Flower Mound
Flower Mound, Texas 75028
United StatesActive - Recruiting
Ultimate Bariatrics - Fort Worth
Fort Worth, Texas 76102
United StatesActive - Recruiting
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