New data from a multi-center, randomized clinical trial indicate that the EndoBarrier is a safe, noninvasive device with excellent short-term weight loss results in morbidly obese patients. These data showed that patients treated with the EndoBarrier lost on average, triple the weight of their diet control group. Specifically, at just 12 weeks, the device group lost 13.7kg (30.2lbs) versus 4.4kg (9.7lbs) for the control group.
The company also said that that the device had a beneficial effect on type 2 diabetes, resulting in lower blood glucose levels or a reduction in diabetic medication for patients.
The clinical trial was designed to examine the safety and efficacy of the EndoBarrier in morbidly obese patients. In a multi-center, randomized clinical trial, 37 patients were treated-26 received the EndoBarrier gastrointestinal liner and 11 were in the diet control group.
The EndoBarrier was implanted for 12 weeks and some of these patients were allowed to continue for an additional 12 weeks. Approximately four patients continued beyond the initial 12 weeks. Patients in both the EndoBarrier and diet control groups followed the same diet during the study period. Starting average weight for these two groups was similar with 142.3kg (313lbs) for EndoBarrier patients versus 137.5kg (303.2lbs) for control group patients, and body mass index of 48.2 versus 49.2, respectively.
The data show that at three months, EndoBarrier patients experienced a mean excess weight loss of 19% versus 6.9% (p<0.001) in the diet control group. In the eight patients with type 2 diabetes, all improved dramatically during the study period as evidence by the decrease in blood glucose levels and a reduction in diabetic medication. The mean procedure time was 33 minutes for device implants and 15 minutes for device explants.