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Spatz3 Adjustable Balloon System® (Spatz3) Post Approval Study

Spatz FGIA, Inc · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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obesity
A prospective, Multicenter open-label post approval trial for adults with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The study aims to demonstrate that the safety of the device in the post market setting is comparable to what was observed in the US pivotal study.
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