Obalon Navigation/Touch System Post-Approval Study
Status unconfirmed
Conditions studied: Obesity
In brief
Post-approval study for the Obalon Navigation/Touch System (NTS)
Key facts
- Study ID
- NCT04095481
- Run by
- Obalon Therapeutics, Inc.
- People needed
- 1600
- Starts
- 2019-12-03
- Expected to finish
- 2023-05-30
- Last updated by the study team
- 2019-12-23
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ages 22 years and older
- Starting or current therapy BMI of 30.0-40.0 kg/m2
- Commercially purchased the Obalon Balloon Device
You may not qualify if…
- 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.
Where it is running
- Ultimate Bariatrics - Flower Mound — Flower Mound, Texas, United States (enrolling)
- Ultimate Bariatrics - Fort Worth — Fort Worth, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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