title: A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon (SAB) for obesity.
abstract: BACKGROUND
  A 150 cm pear-shaped gastric balloon with a 30 cm-long duodenal stem and a 7 g metallic weight at its distal end was designed and developed to facilitate weight loss by (a) delaying gastric emptying thus enhancing interprandial satiety, and (b) stimulating antral and duodenal receptors of satiation.
  
  
  METHODS
  Twenty-six patients (body mass index of 29 to 40 kg/m) who failed to lose weight despite dietary intervention underwent endoscopic implantation of the balloon device. Patients were monitored for tolerance to the balloon, complications, weight loss, and compliance with a restricted caloric intake.
  
  
  RESULTS
  Six men and 20 women with a median body weight of 93.0 kg (range, 73.5 to 119.9), median body mass index 34.3 kg/m (range, 28.8 to 39.5) underwent balloon implantation for a median period of 4.0 months (range, 0.75 to 6.0). Twenty-two patients successfully complied with a 1250 to 1500 kcal daily diet restriction during the study period. Median weight reduction was 6.5 kg (range, 3.7 to 19.9). Patients with initial body weight of >90 kg tended to loose more weight (8.1 kg) than patients weighing <90 kg (4.5 kg) (P=0.14). Nine patients with dwell times of 6 months lost 11.5+/-4.6 kg. The balloon malfunctioned in 4 patients (in 1 patient, the balloon leaked spontaneously but remained in the stomach and in 3 patients, the balloon migrated distally).
  
  
  CONCLUSIONS
  Our novel balloon device may be effective in inducing weight loss by promoting compliance with a restricted caloric intake and is well tolerated due to its small size. Complications resulted from balloon rupture, which can be easily prevented by enhancements in design and use of alternative materials.
authors: Sao Paulo University School of Medicine, Sao Paulo, Brazil.
authors: Fabio P
authors: FP
authors: Lopasso
authors: Paulo
authors: P
authors: Sakai
authors: Bashir M
authors: BM
authors: Gazi
authors: Everson L A
authors: EL
authors: Artifon
authors: Christiane
authors: C
authors: Kfouri
authors: Jussara P B
authors: JP
authors: Souza
authors: Atul
authors: A
authors: Kumar
mesh_terms: D000328:Adult; D015992:Body Mass Index; D001938:Brazil; D031204:Caloric Restriction; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D009765:Obesity / Q000178:diet therapy / Q000628:therapy*; D010349:Patient Compliance; D010865:Pilot Projects; D016896:Treatment Outcome; D015431:Weight Loss