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Erschienen in:
Open Access 11.04.2020 | Original Contributions
The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients
Erschienen in: Obesity Surgery | Ausgabe 9/2020
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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.