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Obalon? Balloon System, The Post Approval Study

Primary Objective

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.

Study category: Diabetes & Hormone Disorders

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Type of Study





University of Colorado Hospital

Principal Investigator
Shelby Sullivan,  MD

Shelby Sullivan, MD

Study ID

Protocol Number: 18-1209

More information available at NCT03570034

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