Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System

Ion Endoluminal Procedure for pulmonary nodule

Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied)

Sensitivity for malignancy of the sample obtained

Incidence of all pneumothoraces related to the Ion procedure

Incidence of bleeding in which an intervention was required, related to the Ion procedure. Interventions include: administration of cold saline, vasoactive substances, thrombin, or similar in response to active bleeding; use of bronchial/balloon blocker; use of bronchial artery embolization or resuscitation or ICU admission.

All adverse events related to the Ion procedure

Rate of procedures converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., electromagnetic navigational bronchoscopy] or a different procedure [ex., CT-guided transthoracic needle aspiration]) after the Ion catheter has entered the endotracheal tube. Termination is defined as prematurely ending the procedure after the Ion catheter has entered the endotracheal tube but before the biopsy sample has been obtained.