The ultimate goal of this project is to develop the flexible, non-occlusive ?-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. ?-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 ?-Cuff directly onto the esophagus without altering anatomy or physiology. ?-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. ?-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. ?-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 ?-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 ?-Cuff device, to evaluate the safety of ?- 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 ?-Cuff in Phase III. Public Health Relevance Statement Project NARRATIVE Gastroesophageal reflux disease (GERD) affects millions of Americans. CT Resources has developed a novel device that is an easy and safe surgical option to offer Americans an alternative to current treatments. The device is entering into an early clinical feasibility study to assess performance and safety that will ultimately help to alleviate GERD symptoms and disease progression.
Project Terms: Affect; Anatomy; Anatomic; Anatomic Sites; Anatomic structures; Anatomical Sciences; Back; Dorsum; Barrett Esophagus; Barrett Syndrome; Barrett Ulcer; Columnar Epithelial-Lined Lower Esophagus; Columnar-Lined Esophagus; esophageal intestinal metaplasia; Malignant Neoplasms; Cancers; Malignant Tumor; malignancy; neoplasm/cancer; Chronic Disease; Chronic Illness; chronic disorder; Clinical Protocols; Clinical Research; Clinical Study; Clinical Trials; Corrosion; Deglutition; Swallowing; Deglutition Disorders; Dysphagia; Swallowing Disorders; Diagnosis; Disease; Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Esophageal Stenosis; Esophageal Stricture; Esophagitis; Esophagus; Fatigue; Lack of Energy; Feasibility Studies; Fibrosis; Food; Food or Food Product; Gastroesophageal reflux disease; Acid Reflux; Esophageal Reflux; GERD; Gastro-oesophageal Reflux; Gastroesophageal Reflux; Goals; Gold; Grant; Human; Modern Man; implantable device; biomedical implant; implant device; indwelling device; Lead; Pb element; heavy metal Pb; heavy metal lead; Magnetic Resonance Imaging; MR Imaging; MR Tomography; MRI; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Zeugmatography; Marketing; Nickel; Ni element; Patients; Physiology; Drug Prescriptions; Drug Prescribing; medication prescription; prescribed medication; pressure; Quality Control; Quality of life; QOL; Recommendation; Research Personnel; Investigators; Researchers; Resources; Research Resources; Risk; Safety; Shoes; Stomach; gastric; Stomach Content; Surgical sutures; Sutures; Family suidae; Pigs; Suidae; Swine; porcine; suid; Testing; Time; Time Study; United States; United States Food and Drug Administration; Food and Drug Administration; USFDA; Work; nitinol; Health Care Costs; Health Costs; Healthcare Costs; Device Safety; improved; Procedures; Fundoplication; Nissen Operation; Site; Area; Surface; Clinical; Refractory; Phase; Physiological; Physiologic; Inferior esophageal sphincter structure; Lower Esophageal Sphincter; cardiac sphincter; Reflux; Drug usage; drug use; Disease Progression; Gastroenterologist; Open Bite; Apertognathia; Non-occlusion; Nonocclusion; Openbite; Esophageal Adenocarcinoma; Adenocarcinoma of the Esophagus; Proton Pump Inhibitors; Life; Adopted; Investigation; Hour; Dependence; Side; Techniques; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Operative Surgical Procedures; meetings; Surgeon; American; biocompatibility; biomaterial compatibility; experience; Performance; skills; novel; Amendment; Document Type; Report (document); Devices; Reporting; Adverse Experience; Adverse event; patient safety; Symptoms; Data; Enrollment; enroll; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; Preparation; Process; sample fixation; Fixation; pandemic disease; pandemic; open label; open label study; health related quality of life; design; designing; Outcome; prospective; innovation; innovate; innovative; Resistance; resistant; Implant; commercial application; commercialization; preclinical safety; pre-clinical safety; safety testing; good laboratory practice; flexibility; flexible; arm; metallicity; reduce symptoms; alleviate symptom; ameliorating symptom; decrease symptom; fewer symptoms; relieves symptoms; symptom alleviation; symptom reduction; symptom relief; first-in-human; first in man; feasibility trial; side effect
