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

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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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Acknowledgments

The authors are thankful to the OPAS-1, ORBERA study investigators, included: Rachel Moore, MD (Metairie, LA); Trace Curry, MD (Cincinnati, OH); Ronald Leo, MD (Baton Rouge, LA); Julie Ellner, MD (San Diego, CA); Angelo Coppola, MD (Little Rock, AR); Barham Abu Dayyeh, MD (Rochester, MN); Carl Pesta, DO (Shelby Township, MI); John Olsofka, MD (Louisville, KY); Tiffany Jesse, DO (South Pasadena, FL); Vivek Kumbhari, MD (Baltimore, MD); Ronnie Keith, DO (Norman, OK); and Shakeel Ahmed, MD (Fairview Heights, IL).

Funding

This study was funded by the research grants provided by Apollo Endosurgery, Austin, TX.

Author information

Authors and Affiliations

  1. Surgical Specialists of Louisiana, New Orleans, LA, USA

    Rachel L. Moore

  2. UltaMed Corporation, Fort Lauderdale, FL, USA

    Laura Eaton

  3. Ellner Bariatric, Inc., San Diego, CA, USA

    Julie Ellner

Authors
  1. Rachel L. Moore
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  2. Laura Eaton
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  3. Julie Ellner
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Corresponding author

Correspondence to Rachel L. Moore.

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Conflict of Interest

Laura Eaton is a paid clinical research consultant for Apollo Endosurgery. Drs. Ellner and Moore were clinical investigators for this study and received research grants for study participation. Dr. Moore also reports grants from Obalon, Allurion, and Elira, as well as consulting fees from Medtronic outside of the submitted work.

Ethical Approval

This study was conducted in accordance with the ethical standards of the participating institutions, IRBs, ICH-GCP, and with the 1964 Helsinki declaration and its later amendments.

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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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Moore, R.L., Eaton, L. & Ellner, J. Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. OBES SURG 30, 4267–4274 (2020). https://doi.org/10.1007/s11695-020-04798-5

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  • DOI: https://doi.org/10.1007/s11695-020-04798-5

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