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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: Nutrition and Metabolism

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Details
Age

Adult

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Observational

Scope

National

Location

University of Colorado Hospital

Principal Investigator
Shelby Sullivan,  MD

Shelby Sullivan, MD

Study ID

Protocol Number: 18-1209

More information available at ClinicalTrials.gov: NCT03570034

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