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Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation

肺癌消融的新型微创支气管内方法

基本信息

批准号：
10249490
负责人：
Howard Levin
金额：
$ 78.39万
依托单位：
CORIDEA, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-01 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10249490
关键词：
3-Dimensional Ablation Acute Air Algorithms Animal Model Animals Autopsy Biopsy Bronchoscopes Caliber Cancerous Catheters Cells Chronic Clinical Clinical Pathology Clinical Trials Computer software Contracts Coughing Custom Data Development Devices Diagnosis Dimensions Disease Distal Dose Engineering Ensure Excision Feasibility Studies Fibrosis Fistula Future Goals Grant Health Hemorrhage Histopathology Human Image Incineration Infection Injury Investigation Irrigation Length Lesion Life Lobectomy Lung Lung Neoplasms Malignant Neoplasms Malignant neoplasm of lung Medical Methods Navigation System Nodule Non-Small-Cell Lung Carcinoma Operative Surgical Procedures Pathology Patients Periodicity Peripheral Phase Physicians Pleura Pneumothorax Positioning Attribute Preparation Production Radial Radiation therapy Radiofrequency Interstitial Ablation Risk Running Safety Serious Adverse Event Small Business Innovation Research Grant Stains Structure System Techniques Temperature Testing Therapeutic Thermal Ablation Therapy Time Tissues Tube Unresectable Validation Work base behavior observation chemotherapy clinical effect cost cost effective treatment design effective therapy electric impedance experimental study flexibility healing hemodynamics innovation instrument irritation lung lobe lung preservation meetings microwave ablation minimal risk minimally invasive novel novel therapeutics porcine model pre-clinical preclinical safety preclinical study programs prototype pulmonary function rate of change research and development respiratory response robotic system safety and feasibility safety testing tool tumor tumor ablation verification and validation

项目摘要

PROJECT SUMMARY: Lung cancer is one of the most aggressive and common malignancies world-wide. While surgical resection remains the best chance of cure, only 20% of patients are eligible for surgery. The remaining patients are managed with combinations of radiotherapy and chemotherapy and more recently with less invasive stereotactic radiotherapy and percutaneous thermal ablation. Percutaneous radio-frequency ablation (RFA) or microwave ablation are cost-effective treatment options for unresectable tumors. This minimally invasive approach, though effective for treatment of some stage 1 and 2 non-small cell lung carcinomas either alone or in combination with other therapies, suffer in terms of their ability to create thermal destruction of the tumors with sufficient margin without risking serious adverse events like pneumothorax and collateral injury. The goal of this proposal is to refine the design of a full-length, endobronchial RFA system that is compatible with the working channel of a bronchoscope and can achieve thermal ablation of peripheral nodules 2-3 cm in diameter with minimal risk of pneumothorax. Our innovative approach overcomes past attempts of using RFA to make large lesions without crossing the airway by combining, in a single device, air aspiration and irrigation flow to increase lesion together with a custom RF generator algorithm. Our device is designed to be used with currently available tools for lung tumor biopsy or imaging (e.g., radial EBUS) and can also be used in conjunction with contemporary navigation and robotic systems. This project will be completed in several sequential stages. For this Phase II SBIR we will optimize and refine our innovative approach to RFA, develop a clinical-grade system with verification and validation tests, and demonstrate safety and controllability in preclinical studies. The information obtained in this grant will be used directly to guide EFS-IDE submission with the FDA as part of a future phase of the grant.

项目总结: