This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan.
Time frame: Measure evaluated during entire course of study
Number of needle punctures through the skin
Time frame: Measure evaluated during entire course of study
Number of needle punctures through the pleura
Time frame: Measure evaluated during entire course of study
Number of CT scans needed
Time frame: Measure evaluated during entire course of study
Radial distance at target plane at the needle's final position as shown on the ActiSight screen
Time frame: Measure evaluated during entire course of study
Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization
Time frame: Measure evaluated during entire course of study
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