Abstract
Background
The Elipse Balloon is a swallowable gastric balloon for weight loss that can be deployed
without the use of endoscopy or anesthesia. This study aims to report on 12-month
safety and efficacy outcomes.
Setting
Private hospital, Athens, Greece.
Methods
This was a prospective, nonrandomized open trial. Twelve patients between 18 and 64
years of age with a body mass index (BMI) of 27.0 to 40.0 kg/m2 were enrolled. The Elipse capsule is swallowed with water and its location in the
stomach is confirmed by x-ray. All patients received diet and exercise counseling
only during the therapy period (0–4 mo). Eight months later they were seen in clinic
to assess 12-month outcomes.
Results
There were 7 (58.3%) females and 5 (41.7%) males. The mean age was 41 years, mean
BMI was 35.9 kg/m2, mean weight was 103.5±15.8 kg, and mean waist circumference was 117.6±14.9 cm. All
patients swallowed the balloon. Eleven (91.7%) balloons were filled and were included
in subsequent analysis. All balloons were excreted safely, and no serious adverse
events were reported. Accommodative symptoms were not severe and of very short duration.
Mean excess weight loss percentage and total weight loss percentage were 50.2% and
14.6% at balloon excretion and 17.6% and 5.9% at 12 months, respectively. There was
a statistically significant improvement in patients’ weight, BMI, body fat, waist
circumference, diastolic blood pressure, HbA1C, cholesterol, thyroid stimulating hormone,
aspartate transaminase, and alanine transaminase at balloon excretion. Quality of
life was significantly improved at excretion and 12 months.
Conclusions
This study is the first to demonstrate 12-month efficacy and performance outcomes
of the Elipse Balloon.
Keywords
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Article info
Publication history
Published online: February 20, 2017
Accepted:
February 16,
2017
Received:
October 4,
2016
Identification
Copyright
© 2017 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.
