Real World Registry for Use of the Ion Endoluminal System

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

Detailed Description
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This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield. Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Official Title
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A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System

Conditions
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Lung Cancer, Multiple Pulmonary Nodules, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases

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 index procedure. Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System. Subject able to understand and adhere to study requirements and provide informed consent. Exclusion Criteria: Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord. Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study. Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices. Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.

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, with or without localization, of pulmonary lesion using Ion Endoluminal System<br>Subjects in which a pulmonary lesion biopsy, with or without localization, was attempted or performed with the Ion Endoluminal System. | Device: Ion Endoluminal System<br>* Subjects will under a planned procedure with the Ion Endoluminal System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint to Assess Diagnostic Yield | Defined as the sum of true positives and true negatives divided by the total number of nodules biopsied. Primary outcome analyses will exclude subjects that are enrolled for localization procedure only. | Intra-procedure through the 24 month follow up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint to Assess Pneumothorax | Defined as the incidence of subjects that undergo an Ion Procedure with a pneumothorax event, requiring intervention | Intra-procedure through the 30 day follow up period | 
| Secondary Endpoint to Assess Bleeding | Defined as the incidence of subjects that undergo an Ion Procedure with a bleeding event, with a grade of greater than 2 on the Nashville Scale | Intra-procedure through the 30 day follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary biopsy, pulmonary lesion localization, shape sensing robotic assisted bronchoscopy, ION, Intuitive