In this study, the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions will be evaluated.
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. In this study, the investigators will evaluate the feasibility of a new technique using a robotic endoscope with the Monarch navigational platform to both access and biopsy peripheral pulmonary lesions. The Monarch platform is a "robotic" assisted or electromechanical, software driven endoscopy system designed to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
55
Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Participants With Device or Procedure Related Adverse Events
Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Time frame: 24-84 hours post-procedure
Successful Navigation to Targeted Peripheral Pulmonary Lesions
Successful navigation is confirmed using radial probe endobronchial ultrasound (R-EBUS). the R-EBUS will be inserted into the working channel of the endoscope and advanced beyond the tip of the inner scope as the inner scope is advanced into the lung periphery towards the targeted lesion. As the endoscope is guided towards the targeted lesion, R-EBUS will confirm successful lesion localization prior to biopsies being performed.
Time frame: During the procedure, approximately 1 hour
Incidence of Complications Unrelated to Device
Computed as the number of patients with events unrelated to device or procedure divided by number of patients who underwent the robotic bronchoscopy procedure.
Time frame: 24-84 hours post-procedure
Time to R-EBUS Confirmation (Lesion Localization)
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
Time frame: During the procedure, approximately 1 hour
Total Procedure Time
Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
Time frame: During the procedure
Diagnostic Yield
Determined from the results of the bronchoscopy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Innova Fairfax Hospital
Falls Church, Virginia, United States
Time frame: Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.