title: The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes.
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.
  
  
  METHODS
  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/m2were 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.
authors.affiliation: Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece; Weight Management Program, Holyoke Medical Center, Holyoke, Massachusetts. Electronic address: Raftopoulos_Ioannis@holyokehealth.com.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Raftopoulos
authors.affiliation: Department of Surgery, Iatriko Medical Center, Palaio Faliro, Greece.
authors.forename: Andreas
authors.initials: A
authors.lastname: Giannakou
mesh_terms: D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D004867:Equipment Design; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000628:therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss / Q000502:physiology*; D055815:Young Adult
keywords: intragastric balloon; nonsurgical weight loss; obesity; overweight; swallowable