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

December 19, 2019 updated by: Obalon Therapeutics, Inc.
Post-approval study for the Obalon Navigation/Touch System (NTS)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • Ultimate Bariatrics - Flower Mound
        • Contact:
        • Principal Investigator:
          • Robert Snow, DO, FACOS, FASMBS
      • Fort Worth, Texas, United States, 76102
        • Recruiting
        • Ultimate Bariatrics - Fort Worth
        • Contact:
        • Principal Investigator:
          • Adam B Smith, DO, FACOS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients 22 years and older with a starting therapy BMI of 30.0-40.0 kg/m2 and who commercially purchased the Obalon Balloon device.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obalon NTS
Patients who commercially purchased the NTS Compatible Obalon Balloon System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esophageal Inflation
Time Frame: Up to 20 Weeks
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
Up to 20 Weeks
System Success
Time Frame: 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
Up to 20 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obalon Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • PTL-7410-0007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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