A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB
Trial Parameters
Brief Summary
Multi-center randomized controlled study designed to compare the diagnostic yield of ION™ Endoluminal System with electromagnetic navigation bronchoscopy in patients undergoing transbronchial sampling procedure of peripheral pulmonary nodules.
Eligibility Criteria
Inclusion Criteria: 1. Able to tolerate bronchoscopy; 2. ≥18 years and ≤ 80 years; 3. Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation\*; 4. The pulmonary nodules are solid or part-solid; 5. The maximum diameter of the whole nodule is \>8 mm and ≤30 mm; 6. Chest CT scan results suggest peripheral nodules which are defined as nodules in the Generation 4 or above of the airway (trachea is defined as Generation 0, left and right principal bronchi as Generation 1, lobar bronchi as Generation 2, segmental bronchi as Generation 3, and subsegmental bronchi as Generation 4); 7. Able to understand and adhere to study requirements; 8. Able to provide and sign the informed consent form. Exclusion Criteria: 1. The target nodule has been diagnosed as a malignant tumor or metastatic tumor; 2. The target nodule is later determined as a central lesion (the target nodule is in the airway, and not at a subseg