Multicenter, phase 1, open prospective trial of gastric electrical stimulation for the treatment of obesity: First-in-human results with a novel implantable system
Obesity Surgery Mar 13, 2020
Paulus GF, van Avesaat M, van Rijn S, et al. - Researchers investigated the safety of the Exilis gastric electrical stimulation (GES) system and determined if the settings can be adapted for comfortable chronic use in individuals with morbid obesity. Evaluation of gastric emptying and motility and meal intake was done. The Exilis system was implanted in 20 morbidly obese individuals (17 female, mean BMI of 40.8 ± 0.7 kg/m2) in this multicenter, phase 1, open prospective cohort study. Individuals underwent two blinded baseline test days (GES ON vs OFF), after which long-term, monthly follow-up continued for up to 52 weeks. In all individuals, the procedure was identified as safe, and electrical stimulation was well tolerated and comfortable. GES ON did not differ significantly from GES OFF in gastric emptying halftime (203 ± 16 vs 212 ± 14 min), food intake (713 ± 68 vs 799 ± 69 kcal), insulin AUC (2,448 ± 347 vs 2,186 ± 204), and glucose AUC (41 ± 2 vs 41 ± 2). Outcomes revealed significant but short lasting reduction in weight loss with Exilis GES.
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