Stability and efficacy of an innovative endoscopic gastric bypass sleeve

项目摘要/摘要 肥胖和2型糖尿病是重大的健康风险和经济负担， 美国医疗体系每年超过2450亿美元。肥胖目前影响着超过33%(约1.2亿)的美国人 其中25%-30%(~3000万)的人患上了T2 DM。手术是治疗肥胖症最有效的选择 T2 DM患者存在显著风险，死亡率为0.2%，严重并发症发生率为5%。只有2%的 符合条件的患者选择手术，98%的患者得不到有效的治疗。内窥镜旁路装置有 已被证明是有效的，并有可能降低并发症发生率。然而，由于蠕动的力量， 事实证明，将这些设备保持在胃肠道内的适当位置是非常具有挑战性的。拖拉力 由蠕动产生的压力直接施加在这些设备上，导致从目标位置频繁迁移 网站。到目前为止，这个问题尚未得到成功解决。由于固定不充分，这些装置 经常脱臼或功能障碍，价值有限。因此，安全和持久的固定是一种 尚未解决但迫切需要此类GI设备，以便它们能够保持适当和最佳的功能，并 避免因迁移而引起的并发症。EndObetes已经开发出一种新型的内窥镜锚定系统，可以 固定和固定胃肠道内的内窥镜设备。安全地固定内窥镜旁路套筒可以作为 为肥胖糖尿病患者提供了一种有效的替代治疗选择。EndObetes的目标是商业化 腔内搭桥术作为治疗肥胖症和2型糖尿病的一种选择，将比手术更安全、更有效 药物治疗。在此，我们建议评估一个新的原型EndoBypass装置的安全性和有效性。这 将通过以下目标实现：目标1：改进我们的原型设计和研究 固定的有效性和稳定性。我们将评估食物和液体的迁移和防止进入 肥胖犬模型中的胃；目的2：评估一种去除植入支架部分的技术。 并了解食管壁对该装置的反应。成功 完成这些目标将是准备我们的第二阶段SBIR提案的关键，该阶段的重点将是最后敲定 原型设计；在我们的动物模型中验证其性能；并作为一部分进行小型临床试验 为FDA批准的关键试验铺平了道路。

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.