*3.1.1.2 Efficacy and safety profile*

The first human study assessing the safety and efficacy of the TOGA system took place in 2008, in which 21 morbidly obese individuals with a mean BMI of 43.4 kg/m2 were enrolled [15]. After 6 months, patients had an average EWL of 24.4%. No serious adverse events (SAE) were reported. However, at 6 month follow-up endoscopy, gaps in the staple line were observed in 13 out of 21 patients. After technical improvements of the device, a second human pilot study enrolled 11 patients who met criteria for bariatric surgery [14]. Average BMI decreased significantly from 41.6 kg/m2 before treatment to 33.1 kg/m2 at 6 month follow-up. The same results were seen in a multicenter trial with 1-year outcome, which involved 67 patients with a mean BMI of 41.5 kg/m2 , which dropped to 33.1 kg/m2 at 6 months after the TOGA procedure [16]. A small case study evaluating the effect of TOGA on insulin sensitivity and secretion even demonstrated an amelioration of insulin sensitivity with subsequent reduction of the insulin secretion [17]. Compared to the more effective laparoscopic gastric bypass and biliopancreatic diversion, the TOGA system reached a good therapeutic outcome in terms of weight loss and showed no complications [18]. Based on the evidence available, TOGA has showed to be a feasible and effective procedure to treat obesity with a promising potential for the future. However, a multicenter randomized FDA trial was terminated secondary to lack of efficacy, whereafter the company dissolved, and future applications remain uncertain.
