Status:
RECRUITING
Real World Registry for Use of the Ion Endoluminal System
Lead Sponsor:
Intuitive Surgical
Conditions:
Lung Cancer
Multiple Pulmonary Nodules
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
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 procedur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06004440
Start Date
September 21 2023
End Date
August 1 2030
Last Update
November 13 2025
Active Locations (16)
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1
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States, 32806
2
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
3
Blessing Hospital
Quincy, Illinois, United States, 62301
4
Kansas University Medical Center
Kansas City, Kansas, United States, 66103