A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

Inclusion Criteria:

• Subject was 18 years or older at the time of the procedure
• Biopsy procedure attempted/performed using the Ion Endoluminal System

Exclusion Criteria:

• Biopsy procedure was not attempted with the Ion Endoluminal System
• Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval