PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy. MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy. RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed. CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early italian experience / Genco, A.; Ernesti, I.; Ienca, R.; Casella, G.; Mariani, S.; Francomano, D.; Soricelli, E.; Lorenzo, M.; Monti, M.. - In: OBESITY SURGERY. - ISSN 0960-8923. - STAMPA. - 28:2(2018), pp. 405-409. [10.1007/s11695-017-2877-1]

Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early italian experience

A. Genco;I. Ernesti;R. Ienca;G. Casella;S. Mariani;D. Francomano;E. Soricelli;M. Monti
2018

Abstract

PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy. MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy. RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed. CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.
Elipse; intragastric balloon; overweight; obese treatment; weight loss; surgery; endocrinology; diabetes and metabolism; nutrition and dietetics
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Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early italian experience / Genco, A.; Ernesti, I.; Ienca, R.; Casella, G.; Mariani, S.; Francomano, D.; Soricelli, E.; Lorenzo, M.; Monti, M.. - In: OBESITY SURGERY. - ISSN 0960-8923. - STAMPA. - 28:2(2018), pp. 405-409. [10.1007/s11695-017-2877-1]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1023766
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