Shantanu Gaur

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

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.

Balões intragástricos em obesos de alto risco em um centro brasileiro: experiência inicial

OBJECTIVE to assess the short-term efficacy, tolerance and complications in high-risk morbidly obese patients treated with an intragastric balloon as a bridge for surgery. METHODS we conducted a post-hoc analysis study in a Brazilian teaching hospital from 2010 to 2014, with 23 adult patients with a BMI of 48kg/m2, who received a single intragastric air or liquid balloon. We defined efficacy as 10% excess weight loss, and complications, as adverse events consequent to the intragastric balloon diagnosed after the initial accommodative period. We expressed the anthropometric results as means ± standard deviation, comparing the groups with paired T / Students T tests, when appropriate, with p<0.05 considered statistically significant. RESULTS the balloons were effective in 91.3% of the patients, remained in situ for an average of 5.5 months and most of them (65.2%) were air-filled, with a mean excess weight loss of 23.7kg±9.7 (excess weight loss 21.7%±8.9) and mean BMI reduction of 8.3kg/m2±3.3. Complications (17.3%) included abdominal discomfort, balloon deflation and late intolerance, without severe cases. Most of the participants (82.7%) did not experience adverse effects. We removed the intragastric balloons in time, without intercurrences, and 52.2% of these patients underwent bariatric surgery within one month. CONCLUSION in our center, intragastric balloons can be successfully used as an initial weight loss procedure, with good tolerance and acceptable complications rates.