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.
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.
Study Type
OBSERVATIONAL
Enrollment
691
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Costal Pulmonary Associates
Encinitas, California, United States
Incidence of device or procedure related complications
The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.
Time frame: up to 7 days post procedure
Rate of device or procedure related complications
Individual components of the primary endpoint
Time frame: up to 7 days post procedure
Rate of all pneumothoraxes
Time frame: up to 7 days post procedure
Total procedure time
Time frame: During the procedure
Rate of conversion to conventional bronchoscopic procedure
Time frame: During the procedure
Rate of adverse events unrelated to device or procedure
Time frame: up to 7 days post procedure
Stage at diagnosis
Stage at diagnosis (if applicable) will be evaluated for all robotic-assisted bronchoscopy procedures performed for suspicion of lung cancer
Time frame: up to 24 months post procedure
Diagnostic yield
Diagnostic yield for all robotic-assisted procedure performed for suspicion of lung cancer will be evaluated based on histopathological assessment of acquired tissue samples
Time frame: up to 24 months post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Eisenhower Medical Center
Rancho Mirage, California, United States
The University of Connecticut Health Center
Farmington, Connecticut, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Spectrum Health System
Grand Rapids, Michigan, United States
Minnesota Lung Center, Ltd
Minneapolis, Minnesota, United States
...and 9 more locations
Sensitivity for malignancy
Time frame: up to 24 months post procedure
Rate of post-bronchoscopy infections
Time frame: up to 7 days post-procedure