The aim of the study is to show that the device demonstrates continued performance and safety in a commercial setting. Efficacy of the Six Month Obalon Balloon System will be evaluated utilizing the standard weight loss metrics. Patients will be followed for 12 months (6- months Device therapy and 6-months post-removal). The primary objective is to collect additional safety data with the Obalon Balloon System and confirm the existing safety profile results gathered in PTL-1100-0013, the Obalon Pivotal Study.
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
University of Colorado Hospital
Shelby Sullivan, MD
Protocol Number: 18-1209
More information available at ClinicalTrials.gov: NCT03570034
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