Clinical Trial

Shape-sensing Versus Electromagnetic Robotic Bronchoscopy for Evaluation of PulmoNary LEsions

Study acronym: SERENE
Not Yet Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-08 -> 2027-12 2026-05-29
minor Completion pushed: 2028-08 -> 2028-12 2026-05-29
Trial Details
NCT Number NCT07411989
Lead Sponsor The Cleveland Clinic
Collaborators: Rush University Medical Center
Conditions Peripheral Pulmonary Lesions (PPLs), Lung Nodules
Enrollment 346 participants
Start Date 2026-12
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-28