Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study.

Abstract:

:Background and study aims Conventional gastric balloons for weight loss require endoscopy for placement and removal. The Elipse device is swallowed, resides in the stomach for 4 months, and is then expelled. The objectives of this study were to assess the safety of Elipse and to measure its effects on weight loss, metabolic parameters, and quality of life. Methods Each participant swallowed one Elipse device, which was filled with 550 mL of filling fluid through a thin delivery catheter that was then removed. Weight was measured every 2 weeks, and metabolic parameters and quality of life were assessed at baseline and at trial exit. Results 34 patients, with a mean body mass index of 34.8 kg/m2, were enrolled. All 34 patients successfully swallowed the Elipse device. All adverse events were either self-limiting or resolved with medication. All balloons were safely excreted. At 4 months, the mean percent total body weight loss was 10 %. Mean waist circumference was reduced by 8.4 cm. Improvements were also seen in hemoglobin A1c, triglycerides, low density lipoprotein, and blood pressure. At trial exit, quality of life measures had improved across all domains. Conclusion These results demonstrate clinically significant weight loss with the Elipse, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Elipse therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life.ClinicalTrials.gov identifier: NCT 02802007.

journal_name

Endoscopy

journal_title

Endoscopy

authors

Machytka E,Gaur S,Chuttani R,Bojkova M,Kupka T,Buzga M,Giannakou A,Ioannis K,Mathus-Vliegen E,Levy S,Raftopoulos I

doi

10.1055/s-0042-119296

subject

Has Abstract

pub_date

2017-02-01 00:00:00

pages

154-160

issue

2

eissn

0013-726X

issn

1438-8812

journal_volume

49

pub_type

临床试验,杂志文章,多中心研究
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    journal_title:Endoscopy

    pub_type: 临床试验,杂志文章,随机对照试验

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    pub_type: 杂志文章,多中心研究

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    pub_type: 临床试验,杂志文章

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    pub_type: 杂志文章,评审

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    更新日期:2009-02-01 00:00:00

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    journal_title:Endoscopy

    pub_type: 杂志文章,随机对照试验

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