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
1600 participants
OBSERVATIONAL
2019-12-03
2023-05-30
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 NTS
Patients who commercially purchased the NTS Compatible Obalon Balloon System
Obalon Navigation/Touch System
The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
Interventions
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Obalon Navigation/Touch System
The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
Eligibility Criteria
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Inclusion Criteria
2. Starting or current therapy BMI of 30.0-40.0 kg/m2
3. Commercially purchased the Obalon Balloon Device
Exclusion Criteria
2. Known history of structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
3. Known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\> 2 cm), cancer or any other disorder of the stomach.
4. Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
22 Years
ALL
Yes
Sponsors
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Obalon Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Ultimate Bariatrics - Flower Mound
Flower Mound, Texas, United States
Ultimate Bariatrics - Fort Worth
Fort Worth, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Bryanna Henry
Role: primary
Bryanna Henry
Role: primary
Other Identifiers
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PTL-7410-0007
Identifier Type: -
Identifier Source: org_study_id