This study is designed to evaluate clinical safety and diagnostic accuracy of the
robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform
in a broad range of patients with pulmonary lesions.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04182815.
Despite technological advancements in guided bronchoscopy such as electromagnetic
navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of
peripheral pulmonary lesions remains a challenge due to a number of factors, one of which
may be the ability to gain access to peripheral lesions due to the size and
maneuverability of conventional bronchoscopes. The diagnostic yield of conventional
bronchoscopic approaches for peripheral lesions remains suboptimal.
A novel robotic assisted bronchoscopy procedure now exists for patients with lung
nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc.,
Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30
investigative sites.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationAuris Health, Inc.