A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB

Korábbi kezelés

• Known allergies, sensitivities, or previous allergic reactions to the disinfection reagents for reprocessing of the investigational product;
• Participation in any other interventional or investigational clinical studies within 30 days before enrollment.

Más betegség

• The target nodule has been diagnosed as a malignant tumor or metastatic tumor;
• Any other condition that may increase the risk of bronchoscopic procedure as identified in the evaluation by the PI or bronchoscopist before bronchoscopic procedure;
• Other conditions that the investigators consider not suitable for the subjects to participate in the study;

Egyéb

• The target nodule is later determined as a central lesion (the target nodule is in the airway, and not at a subsegmental or more distal location) during the bronchoscopy before the study procedure starts;
• Contraindications to bronchoscopy;
• Contraindication to intubation, general anesthesia, or over American Society of Anesthesiologists (ASA) score of 3;
• Pregnancy;

• Able to tolerate bronchoscopy;
• ≥18 years and ≤ 80 years;
• Chest CT scan results suggest one or more pulmonary nodules and suspected pulmonary malignant tumor which requires further diagnostic evaluation*;
• The pulmonary nodules are solid or part-solid;
• The maximum diameter of the whole nodule is >8 mm and ≤30 mm;
• 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);
• Able to understand and adhere to study requirements;
• Able to provide and sign the informed consent form.