A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
A Multi-Center, Prospective, Single-Arm, Observational Study to Evaluate Real-World Outcomes for the Shape-Sensing Ion Endoluminal System
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Clinical Trial Information
Trial Contact: Rodriguez Saavedra, Carlis M; Simoni, Christine; Caldwell, Chloe M
Trial Phone: 321.841.6764 ; 321.841.7293 ; (321)841.1107
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IRB No: WCG 20231909
Protocol Abbrev: ISI-ION-003
Principal Investigator: Ali Z. Jiwani, MD
Age Group: Adult
Secondary Protocol No: ISI-ION-003
ClinicalTrials.gov ID: NCT06004440
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Objective
The overall clinical objective of this study is to evaluate the procedure characteristics and short-and- long term outcomes following shape-sensing, robotic-assisted bronchoscopy (ssRAB) when utilizing the Ion Endoluminal System for lung lesion biopsy or localization procedures.
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Key Eligibility
Inclusion Criteria:
1. Subject is 18 years or older at the time of the index procedure.
2. Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
3. Subject able to understand and adhere to study requirements and provide informed consent.
