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.

项目概要/摘要 肥胖和 2 型糖尿病 (T2DM) 是重大的健康风险和经济负担，导致 美国医疗保健系统每年价值超过 2450 亿美元。目前美国超过 33%（约 1.2 亿）人口患有肥胖症 其中 25-30%（约 30 M）的人口患有 T2DM。手术是治疗肥胖最有效的方法 T2DM 患者存在显着风险，死亡率为 0.2%，严重并发症发生率为 5%。仅 2% 符合条件的患者选择手术治疗，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，并且有可能降低并发症发生率。但由于蠕动的力量， 事实证明，将这些装置维持在胃肠道内的正确位置非常具有挑战性。阻力 蠕动产生的压力直接作用在这些设备上，导致频繁从目标位置迁移 网站。迄今为止，这个问题尚未得到成功解决。由于固定不充分，这些装置 经常会移位或功能失调，价值有限。因此，安全耐用的固定是一个 对此类胃肠道设备的未解决但至关重要的需求，以便它们能够保持在适当的位置以实现适当和最佳的功能，并 避免因迁移而引起的并发症。 EndObetes 开发了一种新型内窥镜锚定系统，可以 稳定并固定胃肠道内的内窥镜装置。安全固定内窥镜旁路套管可以作为 对于肥胖糖尿病患者来说，这是一种有效的替代治疗选择。 EndObetes 的目标是商业化 EndoBypass 作为肥胖和 T2DM 的一种治疗选择，比手术更安全、更有效 药物。在此，我们建议评估新型 EndoBypass 设备原型的安全性和有效性。这 将通过以下目标来实现： 目标 1：完善我们的原型设计并进行调查 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 肥胖狗模型的胃；目标 2：评估去除植入物嵌入支架部分的技术 该设备并了解食管壁对该设备的存在的反应。成功的 完成这些目标对于准备我们的第二阶段 SBIR 提案至关重要，该提案的重点是最终确定 原型设计；验证其在我们的动物模型中的表现；并进行小型临床试验作为一部分 获得 FDA 批准的关键试验的途径。