Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Capable and willing to give informed consent
Acceptable candidate for an elective, non-emergent bronchoscopic procedure
Solid peripheral lung lesions suspected of malignancy, between 1-5cm in size identified on thin slice CT scan within 14 days of the intended bronchoscopy procedure
Lack bleeding disorders

Exclusion Criteria

Medical contraindication to bronchoscopy
Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure chest CT
Patients with endobronchial involvement seen on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
Participation in any other investigational clinical trial (device or medication) 30 days before and throughout the duration of the study
Uncontrolled or irreversible coagulopathy
Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node involvement

Arm && Interventions

Group	Intervention	Description
Robotic assisted bronchoscopy	Robotic assisted bronchoscopy	Robotic assisted bronchoscopy procedures will be performed using the Monarch platform.

Primary Outcome Measures

Name	Time	Method
Successful Navigation to Targeted Peripheral Pulmonary Lesions	During the procedure, approximately 1 hour	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.
Number of Participants With Device or Procedure Related Adverse Events	24-84 hours post-procedure	Computed as the number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.

Secondary Outcome Measures

Name	Time	Method
Incidence of Complications Unrelated to Device	24-84 hours post-procedure	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 to R-EBUS Confirmation (Lesion Localization)	During the procedure, approximately 1 hour	Defined by the time the robotic bronchoscope is inserted into the oropharynx until the localization of the targeted lesion is confirmed by REBUS.
Total Procedure Time	During the procedure	Defined by the time the robotic bronchoscope is inserted into the oropharynx until the time a biopsy tool is removed.
Diagnostic Yield	Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield.	Determined from the results of the bronchoscopy.

Locations (5): Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Innova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States