This study will evaluate the feasibility of performing robotic navigation of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
Successful biopsy of peripheral pulmonary lesions continues to be 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, investigators will evaluate the feasibility of the Galaxy System, which uses a built-in real-time navigation system called TiLT Technology, to both access and biopsy peripheral pulmonary lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Robotic assisted bronchoscopy of peripheral airways for the purpose of biopsying lung lesions
Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong
Successful tool-in-lesion (defined as the tool within the lesion) as confirmed by CBCT.
Successful navigation of the tool in lesion using the Galaxy System's TiLT technology will be confirmed using Cone Beam Computed Tomography (CBCT) prior to biopsies being performed.
Time frame: During the procedure
Serious device or procedure related adverse events and device deficiencies during the bronchoscopy procedure and post-procedure
Number of patients with device or procedure related adverse events divided by number of patients who underwent the robotic bronchoscopy procedure.
Time frame: Up to 7 days post-procedure
Diagnostic yield
Number of patients who are provided a definitive diagnosis based on the pathology report of the biopsied tissue.
Time frame: Between 7 days and 6 months post-procedure
Center strike as confirmed by CBCT
Number of patients that the tool was confirmed to be in the center of the lesion prior to biopsy.
Time frame: During the procedure
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