Abstract

A1c (HgbA1c) were reduced by 6cm (p o 0.01) and -0.15% (p o 0.05), respectively. Improvements were also seen in triglycerides, HDL, LDL, ALT, and AST. At trial exit, IWQOL-Lite mean scores improved across all domains: þ10.5, þ14.4, þ1.9, þ9.6, þ6.9, and þ9.1 for PF, SE, SL, PD, W, and O, respectively. An improvement of greater than 7.7 in any domain is considered statistically significant. Conclusions: This study demonstrates clinically significant weight loss with ElipseTM, the first procedureless gastric balloon. The weight loss was similar to that seen in prior studies of endoscopically placed balloons. There were no serious adverse events. In addition, ElipseTM therapy led to a significant improvement in waist circumference, HgbA1c, and overall quality of life.

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