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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Lung Cancer, Pulmonary Nodule

Intervention / Treatment
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* Device: Ion Endoluminal System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Ion Endoluminal sampling of pulmonary nodule<br>Subjects in which a pulmonary lesion biopsy was attempted or performed with the Ion Endoluminal System | Device: Ion Endoluminal System<br>* Ion Endoluminal Procedure for pulmonary nodule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Diagnostic yield of the sample obtained through the bronchoscopy procedure, with diagnostic yield defined as (true positives + true negatives)/(total number of lesions biopsied) | Intra-operative through the one year follow up period | 
| Sensitivity for malignancy | Sensitivity for malignancy of the sample obtained | Intra-operative through the one year follow up period | 
| Pneumothorax | Incidence of all pneumothoraces related to the Ion procedure | Intra-operative | 
| Bleeding | 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. | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All adverse events related to the Ion procedure | Intra-operative through 30 days | 
| Conversion to alternate approach or termination of 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. | Intra-operative |