Stability and efficacy of an innovative endoscopic gastric bypass sleeve

创新型内窥镜胃绕道套管的稳定性和有效性

• 批准号: 10010537
• 负责人: Marc Bessler
• 金额: $ 25.06万
• 依托单位: ENDOBETES, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-07 至 2021-10-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010537
• 关键词: Address; Affect; Animal Model; Animals; Body Weight decreased; Bypass; Calories; Canis familiaris; Carbohydrates; Clinical Trials; Complication; Dental crowns; Development; Devices; Diabetes Mellitus; Disease remission; Distal; Economic Burden; Effectiveness; Esophagus; Excision; Food; Food Interactions; Fright; Gastric Bypass; Gastrointestinal tract structure; Glucose; Goals; Health; Healthcare Systems; Implant; Injectable; Intake; Intestines; Liquid substance; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Operative Surgical Procedures; Oral; Oral cavity; Outcome; Partner in relationship; Pathway interactions; Patients; Penetration; Performance; Peristalsis; Pharmaceutical Preparations; Phase; Physiological; Polytetrafluoroethylene; Population; Positioning Attribute; Prevention; Procedures; Rectum; Risk; Safety; Site; Small Business Innovation Research Grant; Stainless Steel; Stents; Stomach; System; Techniques; Thick; Weight maintenance regimen; alternative treatment; bariatric surgery; cost; design; diabetes control; diabetic; diabetic patient; effective therapy; esophageal stents; innovation; migration; minimally invasive; mortality; mortality risk; nitinol; novel; obesity treatment; prevent; prototype; response; sample fixation

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.

项目总结/摘要 肥胖和2型糖尿病（T2 DM）是重大的健康风险和经济负担， 美国医疗保健系统每年超过2450亿美元。肥胖目前影响着美国33%以上的人口（约1.2亿） 其中25-30%（约30 M）的人群发生T2 DM。手术是肥胖症最有效的治疗选择 2型糖尿病患者，但具有显著风险，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治疗，98%的患者得不到有效治疗。内窥镜旁路装置具有 已被证明是有效的，有可能降低并发症发生率。但是由于太阳的引力， 将这些装置保持在胃肠道内的适当位置已经证明是非常具有挑战性的。拖曳力 直接施加在这些器械上，导致从目标位置频繁迁移 网站.这个问题迄今尚未得到成功解决。由于固定不充分，这些器械 经常移位或功能障碍，价值有限。因此，安全和持久的固定是 对此类GI设备的未解决但关键的需求，以便它们能够保持适当和最佳功能， 避免因迁移引起的并发症。EndObetes开发了一种新型的内窥镜锚定系统， 稳定和固定胃肠道中的内窥镜器械。安全地固定内窥镜旁路套管可以用作 肥胖糖尿病患者的有效替代治疗选择。EndObetes的目标是商业化 EndoBypass作为肥胖症和T2 DM的治疗选择，比手术更安全， 药在此，我们建议评价一种新型原型EndoBypass器械的安全性和有效性。这 将通过以下目标实现：目标1：完善我们的原型设计和研究 固定的有效性和稳定性。我们将评估迁移和防止食物和液体进入 肥胖犬模型中的胃; AIM 2：评价取出植入支架部分的技术， 并了解食管壁对器械存在的反应。成功 完成这些目标对于准备我们的第二阶段SBIR建议至关重要，该阶段的重点是最后确定 原型设计;在我们的动物模型中验证其性能;并进行小型临床试验， 一个关键性试验申请FDA批准的途径