Status:
UNKNOWN
Obalon Navigation/Touch System Post-Approval Study
Lead Sponsor:
Obalon Therapeutics, Inc.
Conditions:
Obesity
Eligibility:
All Genders
22+ years
Brief Summary
Post-approval study for the Obalon Navigation/Touch System (NTS)
Detailed Description
The Obalon NTS PAS is a prospective, observational, open-label and multi-center study with an objective to collect continued safety and performance of the Obalon NTS in a commercial setting and confir...
Eligibility Criteria
Inclusion
- Ages 22 years and older
- Starting or current therapy BMI of 30.0-40.0 kg/m2
- Commercially purchased the Obalon Balloon Device
Exclusion
- Known history of structural or functional disorders of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic removal procedure, including, Barrett's esophagus, 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 any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms.
- 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.
- Active implantable devices, such as a pacemaker of defibrillator, or with metal implants in the thoracic region.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2023
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT04095481
Start Date
December 3 2019
End Date
May 30 2023
Last Update
December 23 2019
Active Locations (2)
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1
Ultimate Bariatrics - Flower Mound
Flower Mound, Texas, United States, 75028
2
Ultimate Bariatrics - Fort Worth
Fort Worth, Texas, United States, 76102