Obalon Navigation/Touch System Post-Approval Study

Obesity Clinical Trial

— NTS PAS  

Official title:

Obalon Navigation/Touch System Post-Approval Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095481
• Other study ID #: PTL-7410-0007
• Status: Recruiting
• Start date: December 3, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: December 2019
• Source: Obalon Therapeutics, Inc.
• Contact: Amy VandenBerg
• Phone: 844.362.2566
• Email: ClinicalAffairs[@]obalon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Ultimate Bariatrics - Flower Mound	Flower Mound	Texas
United States	Ultimate Bariatrics - Fort Worth	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Obalon Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal Inflation	Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.	Up to 20 Weeks
Primary	System Success	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	Up to 20 Weeks