Ion Endoluminal System: Subjects will under a planned procedure with the Ion Endoluminal System
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Primary Endpoint to Assess Diagnostic Yield — Intra-procedure through the 24 month follow up period 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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