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Randomized Controlled Trial
. 2021 Nov 27;398(10315):1965-1973.
doi: 10.1016/S0140-6736(21)02394-1. Epub 2021 Nov 15.

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial

Barham K Abu Dayyeh  1 , Daniel B Maselli  2 , Babusai Rapaka  2 , Thomas Lavin  3 , Mark Noar  4 , Hisham Hussan  5 , Christopher G Chapman  6 , Violeta Popov  7 , Pichamol Jirapinyo  8 , Andres Acosta  2 , Eric J Vargas  2 , Andrew C Storm  2 , Fateh Bazerbachi  9 , Marvin Ryou  8 , Matthew French  3 , Sabrena Noria  5 , Daniel Molina  10 , Christopher C Thompson  8
Affiliations
Randomized Controlled Trial

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial

Barham K Abu Dayyeh et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2021 Nov 27;398(10315):1964. doi: 10.1016/S0140-6736(21)02649-0. Lancet. 2021. PMID: 34838178 No abstract available.

Abstract

Background: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity.

Methods: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160.

Findings: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths.

Interpretation: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance.

Funding: Spatz Medical.

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Conflict of interest statement

Declaration of interests BKA reports consultant roles with Endogenex, Endo-TAGSS, Metamodix, and BFKW; consultant and grant or research support from USGI, Cairn Diagnostics, Aspire Bariatrics, Boston Scientific; speaker roles with Olympus, Johnson and Johnson; speaker and grant or research support from Medtronic, Endogastric solutions; and research support from Apollo Endosurgery and Spatz Medical. CGC reports consultant roles with Olympus; consultant roles and payment or honoraria from Apollo Endosurgery and Boston Scientific; payment or honoraria from AbbVie; participation in a data safety monitoring board and consultant roles with Erbe, BFKW, and Nitinotes Surgical. VP reports consultancy fees from Obalon Therapeutics. PJ reports grants from Boston Scientific; patent licensed to Endosim; consulting fees from Endogastric solutions and Erbe; support for meetings from USGI medical; consulting fees and research support from Gastrointestinal Dynamics; and research support from Apollo Endosurgery and Fractyl. AA reports grants from the National Institutes of Health—National Institute of Diabetes and Digestive and Kidney Diseases, American Neurogastroenterology and Motility Society, Mayo Clinic Center for Individualized Medicine; stockholder of Gila Therapeutics and Phenomix Sciences; personal fees from Rhythm Pharmaceuticals, General Mills, Gila Therapeutics; and patent PCT/US62/589915 licensed to Phenomix Sciences. ACS reports institutional research grants from Boston Scientific, Enterasense, Endogenex; consulting fees from Olympus; consulting fees and research grants from Endo-TAGSS, and Apollo Endosurgery; participation in data safety monitoring board with Gastrointestinal Dynamics and Erbe. MR reports consultant roles with Boston Scientific, Fujifilm, Medtronic, Enterasense, and Gastrointestinal Windows; and consultant and research support from Cook Medical. DM reports financial support from Spatz Medical for statistical analysis for this trial. CCT reports institutional research grants from Aspire Bariatrics, Erbe, and Spatz Medical; royalties from Endosim and Enterasense; consulting fees and research grants from Apollo Endosurgery, Boston Scientific, Covidien/Medtronic, Fractyl, Fujifilm, Gastrointestinal Dynamics, Lumendi, Olympus, and USGI; payment or honoraria from Boston Scientific and Olympus; patents licensed to Boston Scientific, Gastrointestinal Windows, Enterasense, EnVision Endoscopy, and Endosim; participation in data safety monitoring board with Gastrointestinal Dynamics, Fractyl, and USGI; leadership or fiduciary role in other board with Enterasense, EnVision Endoscopy, Gastrointestinal Windows, American Society for Gastrointestinal Endoscopy governing board, and BlueFlame Healthcare Venture Fund; stockholder in Gastrointestinal Windows, Enterasense, EnVision Endoscopy; and has received equipment on loan from Fujifilm, Olympus, and Boston Scientific. All other authors declare no competing interests.

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