Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors

Conditions
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Pulmonary Nodule, Lung Cancer

Intervention / Treatment
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* Device: Robotic assisted bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 21 years of age; Capable and willing to give informed consent; Acceptable candidate for an elective, non-emergent bronchoscopic procedure; Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy Exclusion Criteria: Medical contraindication to bronchoscopy as assessed by the investigator Presence of uncorrectable bleeding disorders Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker Patients with the target lesion having endobronchial involvement seen on chest CT Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure, Participation in any other clinical trial within 30 days of enrollment that would interfere with this study; Uncontrolled or irreversible coagulopathy; Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure; CT scan done greater than 28 days before the bronchoscopy procedure.

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 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: Robotic assisted bronchoscopy with Monarch platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 7 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device or procedure related complications | Individual components of the primary endpoint | up to 7 days post procedure | 
| Rate of all pneumothoraxes |  | up to 7 days post procedure | 
| Total procedure time |  | During the procedure | 
| Rate of conversion to conventional bronchoscopic procedure |  | During the procedure | 
| Rate of adverse events unrelated to device or procedure |  | 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 | 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 | up to 24 months post procedure | 
| Sensitivity for malignancy |  | up to 24 months post procedure | 
| Rate of post-bronchoscopy infections |  | up to 7 days post-procedure | 

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