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NCT07735611
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
Conditions: Lung; Node
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 398
Sponsor: Case Comprehensive Cancer Center
Location: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center Cleveland Ohio
Summary
This is an investigator-initiated cluster randomized control trial. The primary objective is to compare the diagnostic yield of two Food and Drug Administration (FDA) cleared national robotic assisted bronchoscopy platforms - the Monarch™ Platform and the ION™ Endoluminal System - in participants undergoing bronchoscopy to evaluate peripheral pulmonary lesions (PPLs). Participants will undergo their scheduled robotic assisted bronchoscopy (RAB) using one of these platforms.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years at the time of bronchoscopy.
* Scheduled to undergo navigational bronchoscopy (either ION™ or Monarch™) for the evaluation of a pulmonary lesion at University Hospitals Cleveland Medical Center (UHCMC).
* Able and willing to provide written informed consent.
Exclusion Criteria:
* Enrolled in another clinical trial that requires the use of a specific navigational/robotic bronchoscopy platform.
* Enrolled in another bronchoscopy-related clinical trial.
* Participant or legally authorized representative declines participation.
Source: ClinicalTrials.gov (NCT07735611). StuddyBuddy aggregates publicly available trial information.