Obalon Navigation/Touch System Post-Approval Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04095481

Acronym

NTS PAS

Enrollment

1600

Registered

2019-09-19

Start date

2019-12-03

Completion date

2023-05-30

Last updated

2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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 confirm results observed in the supplemental PMA IDE study.

Interventions

DEVICEObalon 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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Esophageal Inflation	Up to 20 Weeks	Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
System Success	Up to 20 Weeks	Percentage of appropriate inflation in the stomach with the use of NTS only (without radiography) or correctly determining failed balloon transit (device in the esophagus) as confirmed by endoscopic removal

Countries

United States

Contacts

Primary ContactAmy VandenBerg

ClinicalAffairs@obalon.com844.362.2566

Backup ContactAngel Cardeno