Clinical trial
Allurion Gastric Balloon PAS
Opening soon · Not applicable · 0 countries · Registry ID NCT07684664
What this study is about
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
Basic eligibility
Full registry criteria
Treatments and study arms
Active Elipse Device
Intervention Device
Primary outcomes
Percentage of patients experiencing a procedure- or device-related Serious Adverse Event (Clavien-Dindo Class III or greater) through 48 weeks. The primary objective is to confirm the safety profile of the Allurion Gastric Balloon System (AGBS) in the commercial/post-market setting, consistent with results from the US pivotal study (AUDACITY). All adverse events are coded using MedDRA and classified using the Clavien-Dindo classification system. The endpoint is met if the upper bound of the exact two-sided 95% confidence interval falls below 10%. Analysis is performed on the ITT population (all patients for whom the deployment procedure is attempted).
Study locations
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