The Cleveland Clinic
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.
Millions of nodules are detected every year in the United States. The majority are benign, but some represent early lung cancer and biopsy is often needed to establish the diagnosis. Advanced imaging and navigational guidance systems are routinely used to sample these small peripheral lesions bronchoscopically. A variety of navigational technologies are currently available, including non-robotic electromagnetic navigational bronchoscopy (ENB) and robotic assisted bronchoscopy (RAB), both cleared by the FDA via the 510(k) pathway. Since market release in 2019, few studies, mostly retrospective…
Inclusion Criteria: 1. ≥ 18 years of age at time of bronchoscopy 2. Scheduled for navigational bronchoscopy for the evaluation of pulmonary lesion Exclusion Criteria: 1\. Inability to provide informed consent
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).
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