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Clinical Trial Summary

This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarchâ„¢ Endoscopy Platform in a broad range of patients with pulmonary lesions.


Clinical Trial Description

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 Monarchâ„¢ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04182815
Study type Observational
Source Auris Health, Inc.
Contact
Status Completed
Phase
Start date December 10, 2019
Completion date December 15, 2023

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