Post-approval study for the Obalon Navigation/Touch System (NTS)
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
1,600
The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
Ultimate Bariatrics - Flower Mound
Flower Mound, Texas, United States
RECRUITINGUltimate Bariatrics - Fort Worth
Fort Worth, Texas, United States
RECRUITINGEsophageal Inflation
Percentage of esophageal Inflation during the balloon administrations using the Obalon NTS.
Time frame: Up to 20 Weeks
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
Time frame: Up to 20 Weeks
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