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02.07.2020 | Original Contributions | Ausgabe 11/2020

Obesity Surgery 11/2020

Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting

Zeitschrift:
Obesity Surgery > Ausgabe 11/2020
Autoren:
Rachel L. Moore, Laura Eaton, Julie Ellner
Wichtige Hinweise
Data of individual participants and other study documents will not be shared or made available. Data is on file with the US FDA.

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Abstract

Background and Objectives

Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting.

Methods and Materials

In this multicenter study, 258 adults with a body mass index of 30–40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%.

Results

The incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks).

Conclusions

The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified.

Clinical trial registration: Clinical Trials.​gov NCT02828657

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