Common Contracts
1 similar Certification and Confidentiality Agreement contracts
CERTIFICATION AND CONFIDENTIALITY AGREEMENT:Certification and Confidentiality Agreement • November 22nd, 2021
STUDY OBJECTIVES Evaluate the preliminary safety and performance of the ANET Electrosurgery Applicator (ANET) during and after bronchoscopic ablation of a target pulmonary nodule/tumor. PRIMARY ENDPOINT Safety provided by the evaluation of peri-procedural, device- related adverse events produced by the ANET device used to ablate a target pulmonary nodule/tumor. SECONDARY ENDPOINTS 1. Pathological and histological evaluation of the acute thermal effect, produced by the ANET device, on targeted pulmonary nodule/tumor and surrounding tissue to determine if the observed zone of ablation is localized and consistent with the predicted zone of ablation.2. Characterize any effects on surrounding tissue outside the zone of predicted ablation. OBSERVATIONAL ENDPOINT Characterization of possible immune response changes. STUDY POPULATION Adult subjects with confirmed Stage I or Stage II primary lung cancer with a pulmonary nodule/tumor suitable for ablation by the ANET device via EBUS bronchosco
