The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat type 2 diabetes and obesity, the Lexington, Mass.-based company said.
In the new trial, patients will be monitored out to two years while investigators monitor reductions in HbA1c at one year as a primary endpoint. In the initial stage, GI Dynamics will look to enroll up to 67 subjects, including 50 to be implanted with the EndoBarrier and 17 for the control group. Following an interim safety report to the FDA, the company will apply to expand the enrollment to a total of 240 patients.
“When we announced that the FDA approved our Investigational Device Exemption for the pivotal trial of EndoBarrier, the approval was conditional upon IRB approval. This IRB approval now satisfies that condition. In parallel, we continue to push forward with the clinical study sites that will be part of the 18-1 study and we anticipate being in a position to announce these clinical sites shortly,” prez & CEO Scott Schorer said in a press release.
The approval, which follows FDA approval it won last August, is a boon for the company, which has faced a number of hurdles with its device over the past few years, including shutting down an initial FDA-approved study, being pulled off the shelves in Australia and losing its CE Mark approval in the European Union.