Obalon Navigation/Touch System Post-Approval Study

Obalon Navigation/Touch System Post-Approval Study

Post-approval study for the Obalon Navigation/Touch System (NTS)

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 confirm results observed in the supplemental PMA IDE study.

Inclusion Criteria:

1. Ages 22 years and older
2. Starting or current therapy BMI of 30.0-40.0 kg/m2
3. Commercially purchased the Obalon Balloon Device

Exclusion Criteria:

1. 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.
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.