Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
ConditionLung; Node
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RAB via the Monarch platform
- RAB via the ION platform
Treatment groups
398 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov