A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

Study Overview
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Brief Summary
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The overall objective of this study is to evaluate procedure characteristics of pulmonary nodule biopsies using the integrated version of Cios Spin and the Ion Endoluminal System.

Detailed Description
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This study is a post-market, prospective, multicenter, single-arm study of subjects undergoing a pulmonary nodule biopsy using the Ion Endoluminal System in conjunction with the Cios Spin. The aim of the study is to evaluate the integrated version of the two systems. The primary outcomes of the study are focused on evaluating the procedure characteristics of the pulmonary nodule biopsy procedure, including diagnostic yield, sensitivity for malignancy, and rate of tool in nodule.

Official Title
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A Multicenter Study to Evaluate the Cios Spin and the Ion Endoluminal System for Pulmonary Nodule Biopsy

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Ion Endoluminal System and Cios Spin


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. Pulmonary nodule biopsy attempted/performed using the Ion Endoluminal System and Cios Spin 3D imaging. Pulmonary nodule ≤2 cm in largest diameter. Subject able to understand and adhere to study requirements and provide informed consent. Exclusion Criteria: Planned lymph node staging performed before nodule biopsy. Nodule is a pure ground glass opacity. Plan to biopsy multiple nodules.

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 biopsy of pulmonary nodule using Ion Endoluminal System and Cios Spin<br>Subjects in which a pulmonary nodule biopsy was attempted or performed with the integrated Ion Endoluminal System and Cios Spin | Device: Ion Endoluminal System and Cios Spin<br>* Integrated version of the Ion Endoluminal System and Cios Spin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield | Defined as the sum of true positives and true negatives divided by the total number of nodules (or subjects) biopsied | Intra-procedure through the 13 month follow up period | 
| Sensitivity for malignancy | Defined as the number of true positives divided by the sum of true positives and false negatives for malignancy | Intra-procedure through the 13 month follow up period | 
| Rate of tool in nodule | Tool in nodule is defined as any portion of the needle visualized within the target in all 3 axes (must be confirmed with 3D imaging) | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radiation dose | Radiation dose from biopsy procedure, measured by the dose area product (DAP), defined as the product of dose and beam area (Gy cm^2) | Intra-procedure | 
| Time to achieve tool in nodule | Defined as the time the Ion catheter crosses the endotracheal tube (ETT) to the time tool in nodule is confirmed with 3D imaging | Intra-procedure |