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Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions
Sponsor: The Cleveland Clinic
Summary
This is an investigator-initiated, multicenter, non inferiority, cluster randomized controlled trial. The primary objective is to compare the diagnostic yield of the electromagnetic robotic assisted bronchoscopy with digital tomosynthesis (Galaxy system by Noah Medical) to the shape sensing robotic assisted bronchoscopy with integrated cone beam CT (Ion™ Endoluminal System by Intuitive) in patients undergoing bronchoscopy for peripheral pulmonary lesion (PPL) evaluation.
Official title: Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions: the SERENE Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2026-03
Completion Date
2028-08
Last Updated
2026-03-06
Healthy Volunteers
No
Interventions
Bronchoscopy for peripheral pulmonary lesion biopsy
Participants are scheduled to undergo a bronchoscopy as part of their routine standard of care. Participants will be randomly assigned to one of our two standards of care bronchoscopy robotic platforms (Ion shape sensing robot or Galaxy by Noah electromagnetic robot).
Locations (2)
Rush University Medical Center
Chicago, Illinois, United States
The Cleveland Clinic
Cleveland, Ohio, United States