Robotic Bronchoscopy for Peripheral Pulmonary Lesions

Age Range:18 - 80
Start Date:November 1, 2018
End Date:April 30, 2020
Contact:Scott Rehage

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

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.

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.

Inclusion Criteria:

1. Capable and willing to give informed consent

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

3. 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

4. Lack bleeding disorders

Exclusion Criteria:

1. Medical contraindication to bronchoscopy

2. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure
chest CT

3. Patients with endobronchial involvement seen on chest CT

4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist
prior to procedure

5. Participation in any other investigational clinical trial (device or medication) 30
days before and throughout the duration of the study

6. Uncontrolled or irreversible coagulopathy

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

8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT
abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node
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