Obalon Navigation/Touch System Post-Approval Study

• Conditions: Obesity
• Interventions: Device: Obalon Navigation/Touch System

• Registration Number: NCT04095481
• Lead Sponsor: Obalon Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Status Verified: 2019-12
• Study Start: 2019-12-03
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obalon NTS	Obalon Navigation/Touch System	Patients who commercially purchased the NTS Compatible Obalon Balloon System

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ultimate Bariatrics - Flower Mound; 🇺🇸 Flower Mound, Texas, United States

Ultimate Bariatrics - Fort Worth; 🇺🇸 Fort Worth, Texas, United States