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

Dayyeh, Barham K. Abu; Maselli, Daniel B.; Rapaka, Babusai; Lavin, Thomas; Noar, Mark D.; Hussan, Hisham; Chapman, Christopher G.; Popov, Violeta; Jirapinyo, Pichamol; Acosta, Andrés; Vargas, Eric J.; Storm, Andrew C.; Bazerbachi, Fateh; Ryou, Marvin; French, Matthew; Noria, Sabrena; Molina, Daniel; Thompson, Christopher C.

doi:10.1016/s0140-6736(21)02394-1

Cited by 59 publications

(47 citation statements)

References 29 publications

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“…The results of a multicenter randomized trial that assessed the efficacy and safety of the adjustable Spatz IGB (Spatz FGIA, Great Neck, New York, United States) were recently published. 7 The study reported a significantly higher %TBWL at 32 weeks in the IGB group compared with the lifestyle intervention alone group (15.0 vs. 3.3%, respectively). Overall, 92% of patients in the IGB group achieved more than or equal to5% TBWL.…”

Section: Intragastric Balloonsmentioning

confidence: 83%

Future of Metabolic Endoscopy

Ghazi

Vargas

Abboud

et al. 2022

Journal of Digestive Endoscopy

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Obesity has been escalating as one of the worst public health epidemics. Conservative therapies including lifestyle modifications and weight loss medications have limited efficacy and long-term sustainability. Bariatric surgeries, although effective, remain underutilized due to their cost, safety concerns, and patient acceptance. In the past two decades, endoscopic bariatric and metabolic therapies (EBMTs) have emerged as safe, effective, and less invasive options for the treatment of obesity and its comorbidities, with recent studies reporting favorable outcomes in terms of weight loss and metabolic parameters. This article reviews the major and newly developed EBMTs, with emphasis on their metabolic effects and potential use in the management of metabolic conditions.

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Section: Intragastric Balloonsmentioning

confidence: 83%

Future of Metabolic Endoscopy

Ghazi

Vargas

Abboud

et al. 2022

Journal of Digestive Endoscopy

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“…Additionally, it has been hypothesized that the temporary placement of IGB facilitates the learning of new dietary and behavioral habits. Overall, studies have shown that use of IGB leads to 6%-15% total body weight loss and is an effective treatment option for patients with obesity, including even morbid or treatment resistant cases [15][16][17]. It is well documented that the majority of weight loss occurs in the first 3 months after balloon implantation, however there is slower weight loss ongoing for up to 24 months [18].…”

Section: Accepted Manuscriptmentioning

confidence: 99%

“…Overall, studies have shown that use of IGB leads to 6 to 15% total body weight loss (TBWL) and is an effective treatment option for patients with obesity, including even morbid or treatment-resistant cases. [15][16][17] It is well documented that the majority of weight loss occurs in the first 3 months after balloon implantation; however, there is slower weight loss ongoing for up to 24 months. 18 Longterm data are scant, but one study showed that there are no significant differences seen in total weight loss at 10 years.…”

Section: Introductionmentioning

confidence: 99%

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis

et al. 2022

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Obesity is strongly associated with nonalcoholic fatty liver disease (NAFLD) as well as advanced forms of the disease such as steatohepatitis (NASH), cirrhosis, and hepatocellular carcinoma. While lifestyle and diet modifications have been the cornerstone of treatment for NASH thus far, they are only effective for less than half of the patients. New endoscopic bariatric therapies (EBT) have already proved to be safe and effective for the treatment of obesity and type 2 diabetes mellitus, and may provide an intermediate, less invasive and cost-effective option for patients with NASH. In this review, we aim to describe the data and evidence as well as outline future areas of development for endobariatric therapies for treatment of NASH. In conclusion, EBTs present an effective and safe therapeutic modality for use in the growing pandemic of obesity related liver disease and should be further investigated with large scale trials in this patient population.

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“…The Spatz3 IGB is commercially available in several countries outside the United States. Based on a pivotal randomized trial published in 2021 [21], the Spatz3 balloon was FDA-approved in October 2021.…”

Section: Key Pointsmentioning

confidence: 99%

Endobariatrics: well past infancy and maturing rapidly

Shrestha

Shah

2022

Current Opinion in Gastroenterology

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Purpose of reviewThis review summarizes the key developments with regard to FDA-approved endoscopic bariatric metabolic therapies (EBMTs) in the last 2 years.Recent findingsThe prevalence of obesity has increased during the coronavirus disease 2019 (COVID-19) pandemic, and obesity worsens COVID-19 related outcomes. Several studies have confirmed the safety and short-term efficacy of intragastric balloons (IGBs). In the short-term IGBs may improve steatosis and fibrosis in nonalcoholic fatty liver disease and improve quality of life and mental health. Unfortunately weight loss from these temporarily placed devices is not sustained long-term. Endoscopic sleeve gastroplasty (ESG) may be more effective and durable than IGBs, and result in fewer adverse events compared to bariatric surgery. The recently completed MERIT trial may catapult ESG as a first-line EBMT. Aspiration therapy meets safety and effectiveness thresholds for incorporation into routine practice, but overall acceptance has been lower than other FDA-approved EBMTs.SummaryThe field of endobariatrics is rapidly maturing. Significant knowledge gaps remain with regards to combining EBMTs with pharmacologic therapy to improve durability of weight loss. The rapid expansion in the literature supporting safety and long-term efficacy ESG may prompt revision of existing guidelines.

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

Cited by 59 publications

References 29 publications

Future of Metabolic Endoscopy

Future of Metabolic Endoscopy

Novel Endoscopic Bariatric Therapies for the Management of Nonalcoholic Steatohepatitis

Endobariatrics: well past infancy and maturing rapidly

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