Real World Registry for Use of the Ion Endoluminal System (NCT06004440) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Real World Registry for Use of the Ion Endoluminal System
United States1,301 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Primary Endpoint to Assess Diagnostic Yield
Timeframe: Intra-procedure through the 24 month follow up period