Clinical Feasibility Study of a Novel Flexible, Non-occlusive GERD Treatment Device

新型灵活、非闭塞性胃食管反流病治疗装置的临床可行性研究

• 批准号: 10398986
• 负责人: Claude NMN Tihon
• 金额: $ 56.28万
• 依托单位: CT RESOURCES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10398986
• 关键词: Adopted; Adverse event; Affect; Amendment; American; Anatomy; Area; Back; Barrett Esophagus; Chronic Disease; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Corrosion; Data; Deglutition; Deglutition Disorders; Dependence; Device Safety; Devices; Diagnosis; Disease; Disease Progression; Drug Prescriptions; Drug usage; Enrollment; Esophageal Adenocarcinoma; Esophageal Stenosis; Esophagitis; Esophagus; Family suidae; Fatigue; Feasibility Studies; Fibrosis; Food; Fundoplication; Gastroenterologist; Gastroesophageal reflux disease; Goals; Gold; Grant; Health Care Costs; Hour; Human; Implant; Inferior esophageal sphincter structure; Investigation; Lead; Life; Magnetic Resonance Imaging; Malignant Neoplasms; Marketing; Nickel; Open Bite; Operative Surgical Procedures; Outcome; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Physiological; Physiology; Preparation; Procedures; Process; Proton Pump Inhibitors; Quality Control; Quality of life; Recommendation; Reflux; Refractory; Report (document); Reporting; Research Personnel; Resistance; Resources; Risk; Safety; Shoes; Side; Site; Small Business Innovation Research Grant; Stomach; Stomach Content; Surface; Surgeon; Surgical sutures; Symptoms; Techniques; Testing; Time; Time Study; United States; United States Food and Drug Administration; Validation; Work; arm; biomaterial compatibility; commercial application; commercialization; design; experience; feasibility trial; first-in-human; flexibility; good laboratory practice; health related quality of life; implantable device; improved; innovation; meetings; metallicity; nitinol; novel; open label; pandemic disease; patient safety; preclinical safety; pressure; prospective; reduce symptoms; safety testing; sample fixation; side effect; skills

PROJECT SUMMARY/ABSTRACT The ultimate goal of this project is to develop the flexible, non-occlusive Ω-Cuff as a simple and safe device to treat gastroesophageal reflux disease (GERD). GERD is the inability of the lower esophageal sphincter (LES) to keep the acidic stomach content from coming back up excessively into the esophagus that can cause major discomfort, disrupting daily lives and can lead to esophagitis, Barrett's esophagus, strictures, and cancer. 40 million U.S. GERD patients manage their symptoms by life-long prescription medications such as Proton Pump Inhibitors (PPIs) of whom 16 million will need other options due to either ineffectiveness or side effects. GERD is the most expensive of all the GI diseases, with an annual U.S. healthcare cost >$12 billion and growing. Due to its risks and significant physiological perturbations, the gold standard fundoplication surgery treats <30 thousand patients. Ω-Cuff improves upon a less morbid partial fundoplication surgery by having a simpler, easier, safer and more durable treatment. A straightforward laparoscopic procedure places the Ω-Cuff directly onto the esophagus without altering anatomy or physiology. Ω-Cuff works symbiotically with the esophagus to mitigate dysphagia common to other surgical treatments, to reduce medication dependence and healthcare costs. We successfully completed the required preclinical safety tests. Ω-Cuffs were manufactured and implanted over the LES area in a 1-year, 24-pigs Good Laboratory Practice (GLP) study without adverse events. The device could be safely explanted. Ω-Cuff passed the panel of ISO 10993 biocompatibility, corrosion, nickel leaching, and fatigue cycling durability tests. It was also found to be MRI compatible at both the 1.5 and 3.0 Tesla levels, allowing patients to safely go through standard MRI diagnoses, if needed. An Investigational Device Exemption (IDE) has been granted by the Food and Drug Administration (FDA) for a clinical feasibility study. This proposal has the following aims. Specific Aim 1: Manufacture Ω-Cuff in 5 sizes for the clinical study. Per FDA mandate, we will manufacture 5 sizes (20 each) for the clinical study. Specific Aim 2: Conduct human clinical early feasibility study with 8 patients. The study is an observational, prospective, non- randomized, open label, feasibility study of patients receiving the Ω-Cuff device, to evaluate the safety of Ω- Cuff and its ability to reduce the GERD symptoms in augmenting the function of the LES. Specific Aim 3: Prepare report and document for an IDE amendment to expand into a pivotal study. The intent of this clinical feasibility study is to establish a basis for expanding into a pivotal study to complete the clinical validation process. Commercialization will commence after completion of the pivotal clinical study and receiving approval from the FDA to market Ω-Cuff in Phase III.

项目概要/摘要 该项目的最终目标是开发灵活、非闭塞的 Ω-Cuff 作为一种简单且安全的设备，以 治疗胃食管反流病（GERD）。 GERD 是食管下端括约肌 (LES) 功能障碍 防止酸性胃内容物过多回流到食道，从而导致严重的胃溃疡 不适，扰乱日常生活，并可能导致食管炎、巴雷特食管、狭窄和癌症。 4000 万美国 GERD 患者通过终身处方药（例如 Proton）来控制症状 泵抑制剂 (PPI) 由于无效或副作用，其中 1600 万人将需要其他选择。 GERD 是所有胃肠道疾病中最昂贵的，美国每年的医疗费用超过 120 亿美元， 生长。由于其风险和显着的生理干扰，金标准胃底折叠术 治疗<30,000名患者。 Ω-Cuff 通过具有 更简单、更容易、更安全、更持久的治疗。简单的腹腔镜手术将 Ω-Cuff 直接进入食道而不改变解剖学或生理学。 Ω-Cuff 与 食管以减轻其他手术治疗常见的吞咽困难，减少药物依赖性和 医疗费用。 我们成功完成了所需的临床前安全测试。制造并植入Ω-Cuffs 在一项为期 1 年、24 头猪的良好实验室规范 (GLP) 研究中，在 LES 区域没有出现不良事件。这 装置可以安全地移植。 Ω-Cuff通过ISO 10993生物相容性、腐蚀、镍面板 浸出和疲劳循环耐久性测试。它还被发现在 1.5 和 3.0 下均兼容 MRI 特斯拉水平，允许患者在需要时安全地进行标准 MRI 诊断。研究性的 设备豁免 (IDE) 已获得美国食品和药物管理局 (FDA) 的临床可行性批准 学习。该提案有以下目的。具体目标 1：制造 5 种尺寸的 Ω-Cuff 供临床使用 学习。根据 FDA 的要求，我们将为临床研究生产 5 种规格（每种 20 种）。具体目标 2：行为 涉及 8 名患者的人体临床早期可行性研究。该研究是一项观察性、前瞻性、非 对接受 Ω-Cuff 装置的患者进行随机、开放标签的可行性研究，以评估 Ω- 的安全性 Cuff 及其减轻 GERD 症状、增强 LES 功能的能力。具体目标 3： 为 IDE 修订准备报告和文件，以扩展为关键研究。本次临床试验的目的 可行性研究是为扩展为关键研究以完成临床验证奠定基础 过程。商业化将在关键临床研究完成并获得批准后开始 FDA 批准 Ω-Cuff 进入 III 期上市。