Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setti
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ORIGINAL CONTRIBUTIONS
Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting Rachel L. Moore 1
&
Laura Eaton 2 & Julie Ellner 3
# Springer Science+Business Media, LLC, part of Springer Nature 2020
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 postmarketing 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 Keywords Obesity . Weight loss . Weight reduction . Clinical trials
Introduction Obesity and its related comorbidities, such as diabetes, hypertension, and hypercholesterolemia, are associated with serious health risks [1]. The prevalence of obesity among the US adults is soaring. In 2015–2016, the prevalence of obesity among the US adults was nearly 40% [2]. The efficacy of intragastric balloons (IGBs) at promoting weight loss has been widely documented in multiple global clinical studies in the
Data of individual participants and other study documents will not be shared or made available. Data is on file with the US FDA. * Rachel L. Moore [email protected] 1
Surgical Specialists of Louisiana, New Orleans, LA, USA
2
UltaMed Corporation, Fort Lauderdale, FL, USA
3
Ellner Bariatric, Inc., San Diego, CA, USA
past 20 years [3–22]. There is also evidence in the literature to support improvement in obesity-related comorbidities with IGB [11, 13, 17, 23–26]. Many clinical studies have also assessed the improvements in quality of life that accompany weight loss due to treatment with the IGB System [7, 13, 17, 27]. The ORBERA® Intragastric Balloon System (IGB), previously known as the BIB™, has been in use outside of the USA for 23 years and now for nearly 5 years in the USA (approved August 5, 2015), with over 280,000 devices distributed globally [28]. It has a well-documented safety, effectiveness, and acceptability profile [29]. The IGB produces weight lo
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