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.
Endoscopic adrenalectomy can safely be performed-even sporadically-by surgeons well versed in adrenalectomy techniques for endocrine disorders and trained in endoscopic surgery.
The Proring-Band appeared simpler in its use, during preparatory extra-body handling, placement and fixation. Considering its flexibility, its flat part and its smooth edges, the Proring-Band appears to present less risk of dysphagia, rupture and migration. This situation will be evaluated in a comparative blind study with a follow-up of more than 2 years. The Proring-Band ring is manufactured, sterilized and marketed by a pharmaceutical company. The use of this ring, provided as a medical device designed for restrictive surgery, assures to the surgeon a reproducibility of the material and of the sterilization conditions.
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