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.
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 the clinic to assess 12-month outcomes.
Results:
There were 7 (58.3%) females and 5 (41.7%) males. The mean age was 41 years, the mean BMI was 35.9 kg/m2, the mean weight was 103.5±15.8 kg, and the 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 analyses. 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 the 12-month efficacy and performance outcomes of the Elipse Balloon.
Kommentare