SBIR/STTR Award attributes
PROJECT SUMMARYLung cancer is one of the most aggressive and common malignancies world wideWhile surgical resection remains the best chance of cureonlyof patients are eligible for surgeryThe remaining patients are managed with combinations of radiotherapy and chemotherapy and more recently with less invasive stereotactic radiotherapy and percutaneous thermal ablationPercutaneous radio frequency ablationRFAor microwave ablation are cost effective treatment options for unresectable tumorsThis minimally invasive approachthough effective for treatment of some stageandnon small cell lung carcinomas either alone or in combination with other therapiessuffer in terms of their ability to create thermal destruction of the tumors with sufficient margin without risking serious adverse events like pneumothorax and collateral injuryThe goal of this proposal is to refine the design of a full lengthendobronchial RFA system that is compatible with the working channel of a bronchoscope and can achieve thermal ablation of peripheral nodulescm in diameter with minimal risk of pneumothoraxOur innovative approach overcomes past attempts of using RFA to make large lesions without crossing the airway by combiningin a single deviceair aspiration and irrigation flow to increase lesion together with a custom RF generator algorithmOur device is designed to be compatible with contemporary navigation systems and could be used in conjunction with currently available tools for lung tumor biopsy or imaginge gradial EBUSThis project will be completed in several sequential stagesFor this Phase I SBIR we will demonstrate proof of technical concept that our innovative approach to RFA with a device completely in the airway can make large lesions in preclinical models without causing acute pneumothorax despite close proximity to the pleuraSuccessful completion of the specific aims will lead to the development of a clinical grade device that can be validated and verified with modern navigation tools to safely and effectively ablate tumor phantoms planned for Phase II of the project Current therapies to treat non small cell lung cancerNSCLChave significant limitationssubstantial costsand are not suitable for all patientsThis proposal will validate a new method for NSCLC ablation that we believe will ultimately become an important therapeutic option for treating inoperable patients with early stage NSCLC
