Obalon Navigation/Touch System Post-Approval Study

Last updated: December 19, 2019
Sponsor: Obalon Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04095481
PTL-7410-0007
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Known history of structural or functional disorders of the esophagus that may impedepassage of the device through the gastrointestinal tract or increase risk ofesophageal damage during an endoscopic removal procedure, including, Barrett'sesophagus, 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 anyswallowing disorder, esophageal chest pain disorders, or drug refractory esophagealreflux symptoms.

  3. Known history of structural or functional disorders of the stomach including,gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2cm), cancer or any other disorder of the stomach.

  4. Active implantable devices, such as a pacemaker of defibrillator, or with metalimplants in the thoracic region.

Study Design

Total Participants: 1600
Study Start date:
December 03, 2019
Estimated Completion Date:
May 30, 2023

Study 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.

Connect with a study center

  • Ultimate Bariatrics - Flower Mound

    Flower Mound, Texas 75028
    United States

    Active - Recruiting

  • Ultimate Bariatrics - Fort Worth

    Fort Worth, Texas 76102
    United States

    Active - Recruiting

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