Stability and efficacy of an innovative endoscopic gastric bypass sleeve

PROJECT SUMMARY/ABSTRACT Obesity and type-2 diabetes mellitus (T2DM) are significant health risks and an economic burden, costing the US healthcare system over $245 billion annually. Obesity currently affects over 33% (~120 M) of the US population of which 25-30% (~30 M) develop T2DM. Surgery is the most effective treatment option for obese patients withT2DM but carries significant risk with 0.2% mortality and 5% serious complication rates. Only 2% of eligible patients are choosing surgery, leaving 98% without effective treatment. Endoscopic bypass devices have been shown to be effective with a potential for lower complication rates. However due to the force of peristalsis, maintaining these devices in proper position within the GI tract has proven very challenging. The drag force created by peristalsis is directly exerted on these devices causing frequent migration from the targeted placement sites. This problem has not been successfully addressed to date. As a result of inadequate fixation these devices frequently become dislodged or dysfunctional and are of limited value. Thus, safe and durable fixation is an unsolved but critical need for such GI devices so they can stay in place for proper and optimal function and to avoid complications due to migration. EndObetes has developed a novel, endoscopic anchoring system that can stabilize and fixate endoscopic devices in the GI tract. Safely fixing an endoscopic bypass sleeve may serve as an effective, alternative treatment option for obese diabetic patients. EndObetes’ goal is to commercialize EndoBypass as a treatment option for obesity and T2DM that will be safer than surgery and more effective than medication. Herein we propose to evaluate the safety and efficacy of a novel prototype EndoBypass device. This will be accomplished through the following aims: AIM 1: Refine our prototype design and investigate effectiveness and stability of fixation. We will evaluate migration and prevention of food and liquid from entering the stomach in an obese dog model; AIM 2: Evaluate a technique for removal of the embedded stent portion of the device and to understand the response of the esophageal wall to presence of the device. Successful completion of these Aims will be critical for preparing our Phase II SBIR proposal, which will focus on finalizing the prototype design; validating its performance in our animal model; and performing a small clinical trial as part of the pathway to a pivotal trial for FDA approval.PROJECT NARRATIVE A highly effective alternative to bariatric surgery for weight loss and type 2 diabetes mellitus with has a lower complication rate is highly desirable. We have developed a novel endoscopic bypass device, EndoBypass, which employs an endoscopic anchoring system that stabilizes and fixes it in place in the GI tract, thereby making it an effective treatment option for obese and diabetic patients. Herein we propose to continue development of our EndoBypass device to evaluate the safety, efficacy, and physiological effects in an obese dog model.