The purpose of this study is to evaluate the safety and performance of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer.
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs. This feasibility study is being conducted to assess the safety and yield of the LungPoint ATV System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer. Navigation to and sampling of the patient's lung cancer tumor is conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
6
The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
Thoraxklinik
Heidelberg, Germany
Number of serious adverse events
The number of serious adverse events (SAEs) rated as probably or definitely related to the study device and/or procedure divided by the number of patients in whom an attempt at study device use was made. This study protocol focuses specifically on sub-chronic pneumothorax, but will also track hemoptysis.
Time frame: Up to 24 hours post procedure
Proportion of biopsies yielding tissue sufficient for diagnosis
The number of nodules with at least one biopsy sufficient for a tissue diagnosis divided by the number of nodules sampled by the LP ATV System.
Time frame: Upon asssessment of histology of tissue sample taken during procedure
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