PRECIsE: A Prospective Evaluation of the Clinical Utility for the Ion Endoluminal System
The goal of this prospective, multi-center, single-arm, clinical study is to evaluate the clinical utility and performance of the FDA-cleared Ion™ Endoluminal System (Ion) for bronchoscopically approaching and facilitating the tissue sampling of pulmonary nodules.
• Patients aged 18 years and older
• Patient is suitable for elective bronchoscopy
• Patients with a moderate to high risk of lung cancer based on clinical, demographic and radiologic information or with suspected metastatic disease
• Solid or semi-solid pulmonary nodules of ≥ 1cm and ≤ 3cm in largest dimension
• Nodule is located in bronchial generation 4+ (i.e. beyond segmental bronchus\*
• Patients are candidates for CT-guided needle biopsy and/or surgical resection
• Patient able to understand and adhere to study requirements
• Patient able to understand and adhere to study requirements and able to provide informed consent
• Patient not legally incapacitated or in legal/court ordered institution
• Patients with no dependency on the investigator or sponsor