Robotic Systems Evaluation for Peripheral Pulmonary Lesions: A Randomized Trial (RISE Trial)
Case Comprehensive Cancer Center
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.
Description
Roughly 1.6 million lung nodules are identified every year in the United States. When tissue sampling is required, robotic-assisted bronchoscopy (RAB) systems are increasingly used to reach peripheral targets inaccessible to standard bronchoscopy. Robotic-assisted bronchoscopy (RAB) has rapidly evolved as a promising modality for sampling PPLs. Two FDA-cleared robotic platforms are currently in clinical use: the ION™ Endoluminal System (Intuitive Surgical, Inc., Sunnyvale, CA) and the Monarch™ Platform (Johnson \& Johnson MedTech / Auris Health, Redwood City, CA). Both platforms were cleared…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.
Interventions
- ProcedureRAB via the Monarch platform
The Monarch™ (Monarch) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses a hybrid approach combining electromagnetic tracking and robotic catheter control with a continuously visualizing bronchoscope (4-way articulation). A key feature of the Monarch platform is direct bronchoscopic vision throughout navigation, enabling real-time assessment of the airways and the target lesion.
- ProcedureRAB via the ION platform
The ION™ Endoluminal System (ION) platform is one of two FDA-cleared robotic platforms currently in clinical use for robotic-assisted bronchoscopy (RAB). It uses shape-sensing fiber-optic technology to track catheter position with high precision throughout the bronchial tree.
Location
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio