RecruitingNCT06004440
Real World Registry for Use of the Ion Endoluminal System
A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
Sponsor
Intuitive Surgical
Enrollment
3,000 participants
Start Date
Sep 21, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria4
- 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.
Interventions
DEVICEIon Endoluminal System
Subjects will under a planned procedure with the Ion Endoluminal System
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06004440
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