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.

项目摘要/摘要 该项目的最终目标是开发灵活的，非熟悉的ω-cuff作为一种简单安全的设备 治疗胃食管反射疾病（GERD）。 GERD是下部食道括约肌（LES）的无力 为了防止酸性失速含量重新回到食道，可能引起主要 不适，破坏日常生活，可能导致食管炎，巴雷特的食管，狭窄和癌症。 4000万美国GERD患者通过终身处方药（例如质子）来管理症状 由于无效或副作用，其中1600万次泵抑制剂（PPI）将需要其他选择。 GERD是所有胃肠道疾病中最昂贵的，美国的医疗保健费用> 120亿美元， 生长。由于其风险和严重的物理扰动，金标准的基本上手术手术 治疗<3万名患者。 ω-cuff通过具有较少病态的部分抗牙手术来改善 更简单，更容易，更安全，更耐用。直接的腹腔镜程序放置ω-cuff ω-cuff与食道共生，而无需改变解剖学或生理学。 食道减轻其他手术治疗常见的吞咽困难，以减少药物依赖性和 医疗保健费用。 我们成功完成了所需的临床前安全测试。制造并植入ω-cuffs 在没有不良事件的1年，24杆良好的实验室实践（GLP）研究中，在LES区域进行。这 设备可以安全地外观。 ω-cuff通过ISO 10993生物相容性，腐蚀，镍的面板 浸出和疲劳循环耐用性测试。还发现它在1.5和3.0均兼容MRI 特斯拉的水平，使患者可以在需要时安全地进行标准MRI诊断。调查 食品药品监督管理局（FDA）已授予设备豁免（IDE），以实现临床可行性 学习。该提议具有以下目标。特定目标1：为临床制造5个尺寸的ω-cuff 学习。根据FDA的授权，我们将制造5种尺寸（每个20）进行临床研究。特定目标2：行为 人类临床早期可行性研究，对8例患者。该研究是一项观察性，前瞻性，非 - 随机，开放标签，接受ω-cuff设备的患者的可行性研究，以评估ω-的安全性 袖口及其减少GERD症状在增强LE功能方面的能力。具体目标3： 准备报告和文件以进行IDE修正案，以扩展为关键研究。这个临床的意图 可行性研究是为扩展到关键研究以完成临床验证的基础 过程。关键临床研究完成并获得批准后，商业化将开始 从FDA到第三阶段的市场ω-cuff。