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

基本信息

批准号：
10256212
负责人：
Claude NMN Tihon
金额：
$ 59.65万
依托单位：
CT RESOURCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10256212
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 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

项目摘要

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）是指食管下端括约肌（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，由于其风险和显着的生理干扰，胃底折叠术的黄金标准正在不断增长。 Ω-Cuff 治疗<30,000 名患者，通过进行更简单、更容易、更安全、更持久的治疗可通过简单的腹腔镜手术进行 Ω-Cuff 治疗。直接进入食道而不改变解剖学或生理学 Ω-Cuff 与食道共生。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，并植入了 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。 Ω-Cuff通过了ISO 10993生物相容性、腐蚀、镍面板。浸出和疲劳循环耐久性测试还发现它在 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。设备豁免 (IDE) 已获得美国食品和药物管理局 (FDA) 的临床可行性批准该研究有以下具体目标 1：制造 5 种尺寸的 Ω-Cuff 供临床使用。根据 FDA 的要求，我们将为临床研究生产 5 种规格（每种 20 种）。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、非临床性的研究。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 及其减少 GERD 症状、增强 LES 功能的能力具体目标 3：准备 IDE 修订的报告和文件，以扩展为一项关键研究本临床的目的。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。