Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study

Conditions
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Lung; Node

Intervention / Treatment
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* Device: Robotic assisted bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic assisted bronchoscopy<br>Robotic assisted bronchoscopy procedures will be performed using the Monarch platform. | Device: Robotic assisted bronchoscopy<br>* Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.<br>* Other names: Monarch platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | During the procedure, approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | During the procedure | 
| Diagnostic Yield | Determined from the results of the bronchoscopy. | Data was collected (as part of standard of care) through 1-year for calculation of diagnostic yield. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy, Robotic bronchoscopy, Lung cancer, Peripheral lesions