Auris Robotic Endoscopy System for Bronchoscopy

Study Overview
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Brief Summary
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In this study, the performance related to the use of the novel Robotic Endoscopy Platform during bronchoscopic procedures will be evaluated.

Detailed Description
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The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying technologies have been proposed to guide endobronchial biopsies, such as electromagnetic navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy. However, the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is critical to biopsy success. In this study , the novel Robotic Endoscopy Platform and its accessories will be used to provide bronchoscopic visualization of and access to patient airways for diagnostic procedures. Commercially available biopsy instruments will be used to acquire tissue for diagnostic purposes.

Official Title
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A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Robotic Bronchoscopy Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years of age; Capable and willing to give informed consent; Acceptable candidate for an elective, non-emergent bronchoscopic procedure; Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm in size identified on thin slice CT scan with 30 days of the intended bronchoscopy Exclusion Criteria: Medical contraindication to bronchoscopy; Ground glass opacity lesions on pre-procedure CT Participation in any other clinical trial 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; CT scan done over a month before the bronchoscopy procedure. Intra-Procedure Exclusion Criteria: Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the patient's best interest.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Bronchoscopy<br>Robotic bronchoscopy with Robotic Bronchoscopy Platform | Device: Robotic Bronchoscopy Platform<br>* Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.<br>* Other names: The Monarch Platform;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed the Intended Bronchoscopic Procedure With the Robotic Endoscopy Platform | Completion of the intended bronchoscopic procedure is defined by the ability to acquire tissue with biopsy tools. | During the procedure, up to 2 hours |