A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

Study Overview
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Brief Summary
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The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

Detailed Description
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This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

Official Title
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A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

Conditions
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Lung Cancer

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 is 18 years or older at the time of the procedure. Dye marking attempted/performed using the Ion Endoluminal Platform Exclusion Criteria: Resection not performed following dye marking procedure

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 dye marking of pulmonary nodule for resection<br>Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion | Device: Ion Endoluminal System<br>* Ion Endoluminal dye marking procedure for pulmonary nodule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful dye injection | The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample | Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure | 
| Pneumothorax | Incidence of all pneumothoraces related to the Ion procedure | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All adverse events related to the Ion procedure | Intra-procedure until the start of the resection procedure | 
| Procedure time | Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube [ETT]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT). | Intra-procedure | 
| Operative time | Time from start of resection procedure to end of resection procedure (skin-to-skin time) | Intra-operative | 
| Type of resection planned and performed | The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started. | Intra-operative | 
| Conversion to alternate approach or termination of procedure due to localization issues | Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology [ex., open resection] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed. | Intra-operative |