Auris Robotic Endoscopy System for Bronchoscopy

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.

Inclusion Criteria:

1. 18 to 80 years of age;

2. Capable and willing to give informed consent;

3. Acceptable candidate for an elective, non-emergent bronchoscopic procedure;

4. 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:

1. Medical contraindication to bronchoscopy;

2. Ground glass opacity lesions on pre-procedure CT

3. Participation in any other clinical trial 30 days before and throughout the duration
of the study;

4. Uncontrolled or irreversible coagulopathy;

5. Female subjects who are pregnant or nursing or those of child-bearing potential
refusing a pregnancy test;

6. 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.