Obalon Navigation/Touch System Post-Approval Study (NTS PAS)

Obalon Therapeutics

Status

Unknown

Conditions

Obesity

Treatments

Device: Obalon Navigation/Touch System

Study type

Observational

Funder types

Industry

Identifiers

NCT04095481

PTL-7410-0007

Details and patient eligibility

About

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

Full 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 confirm results observed in the supplemental PMA IDE study.

Enrollment

1,600 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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 criteria

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.