Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System

Background and Aims To assess safety of the Exilis (TM) gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated. Method In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 +/- 0.7 kg/m(2)) were implanted with the Exilis (TM) system. Amplitude of the Exilis (TM) system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks. Results The procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203 +/- 16 vs. 212 +/- 14 min, p > 0.05), food intake (713 +/- 68 vs. 799 +/- 69 kcal, p > 0.05), insulin AUC (2448 +/- 347 vs. 2186 +/- 204, p > 0.05), and glucose AUC (41 +/- 2 vs.41 +/- 2, p > 0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p <0.01) reduction in weight loss was observed but not at week 52. At this time point, the mean excess weight loss (EWL) was 14.2 +/- 4.5%. Conclusion Gastric electrical stimulation with the Exilis (TM) system can be considered as safe. No significant effect on food intake, gastric emptying, or gastric motility was observed. The reduction in weight loss with Exilis (TM) GES was significant but short lasting. Further electrophysiological research is needed to gain more insight in optimal stimulation parameters and lead localization.