Recruiting

Obalon Navigation

Sponsor:

Obalon Therapeutics, Inc.

Code:

NCT04095481

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

Obalon Navigation/Touch System

Study Details

Brief summary:

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

Conditions

Obesity

Study ID

NCT04095481

Start date

Dec 3, 2019

Status verified date

Dec, 2019

Completion date

May 30, 2023

Anticipated

Primary completion date

May 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

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

Enrollment

1600 participants

Anticipated

Interventions and Outcome Measures

Arms

Obalon NTS

Patients who commercially purchased the NTS Compatible Obalon Balloon System

Interventions

Obalon 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

Primary outcome measure

  • Esophageal Inflation [ Time Frame: Up to 20 Weeks ]
  • System Success [ Time Frame: Up to 20 Weeks ]

Central Contacts and Locations

Locations

Ultimate Bariatrics - Flower Mound

Recruiting

Flower Mound, Texas, United States, 75028

Contacts

Principal Investigator:

Robert Snow, DO, FACOS, FASMBS

Ultimate Bariatrics - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76102

Contacts

Principal Investigator:

Adam B Smith, DO, FACOS

More Information

Sponsor

Obalon Therapeutics, Inc.

Last update posted

Dec 23, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Obalon Therapeutics, Inc. on 2019-12-23.