Purpose The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. Materials and Methods Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. Results Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). Conclusion The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters.

The objective of the study contained herein was to evaluate the clinical use of the Berg Balance Scale in a heterogeneous acute inpatient rehabilitation population and to assess the relationship between balance scores at admission and rehabilitation outcomes, including functional gain and length of stay. This was a prospective study of 45 patients with diagnoses including stroke (n = 15), traumatic brain injury (n = 19), and other impairments (n = 11) who were admitted for acute inpatient rehabilitation. Functional ability was evaluated with the Functional Independence Measure (FIM) instrument, and balance was measured using the 14-item Berg Balance Scale. These measures were assessed both at admission to and discharge from inpatient rehabilitation. Correlation and multiple regression analyses were used to determine the relationship between balance and functional ability scores at admission and rehabilitation outcomes at discharge, including length of stay, functional gain, and efficiency. Analyses of variance comparing impairment groups indicated that patients with traumatic brain injury were younger than the stroke and other groups, but there were no group differences on FIM or balance scores at admission or discharge. There were no significant group differences for any of the outcome measures. When the impairment groups were collapsed into a single heterogeneous group, multiple regression analyses demonstrated that the sitting unsupported item score at admission accounted for 27% of the variation in length of stay, once demographic influences were controlled. The FIM efficiency score was predicted best by the total Berg Balance Scale score, with 22% of the variance accounted for. In contrast, balance scores did not provide predictive information about the FIM gain score beyond that already provided by the FIM-Total score at admission, which accounted for 10% of the variance once demographics were controlled. Balance scores collected at admission to inpatient rehabilitation, in whole and in part, were shown to account for moderate amounts of variation in length of stay and the FIM efficiency score. For several of the rehabilitation outcomes, balance scores at admission accounted for more variation than scores on the FIM instrument. These findings suggest that routine assessment of balance at admission to inpatient rehabilitation may enhance the ability to predict rehabilitation outcomes beyond that provided by assessment of functional status alone.

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This article was originally published electronically on the publisher’s internet portal on May 5, 2020 without open access.

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