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: 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
• 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

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.

项目总结/文摘