*4.2.2.2 Efficacy and safety profile*

In the first open-label single center trial, 12 patients with a mean BMI of 43.2 kg/m<sup>2</sup> underwent the implantation with the Tantalus system [57]. After 6 weeks of "off"-mode, the system got activated, which resulted in 17.6 ± 4.3% of EWL after a period of 20 weeks. Furthermore, a significant decrease in hunger, assessed with the three-factor eating questionnaire (TFEQ ), was observed. Apart from two SAE including one case of rhabdomyolysis and one case of pulmonary

embolism, the therapy was well tolerated. Both cases resolved completely without the need of surgical intervention, and patients were able to complete the study. In a study assessing the performance of the system, the algorithm was able to detect 73% of meals consumed with a false stimulation rate of 28% [58]. The majority of studies have also demonstrated a good improvement on glucose control in addition to weight loss [50, 59, 60].
