A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Aspiration, Biopsy and RF Ablations
Within an 18-day screening period, eligible subjects will be enrolled into the study and
undergo percutaneous aspiration or percutaneous biopsy or RF ablation utilizing the
ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up
for at least one hour at the clinic for safety and preliminary accuracy evaluations. An
erect chest radiograph will be performed within 90 minutes of observation after chest
aspiration if performed to detect the majority of post procedure pneumothoraces for biopsies
in the chest. Post procedural CT will be performed according to the physician's
consideration. ** Note ** If any complications are observed while using the ActiSight
System, the investigator will revert to using standard procedure.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of target reached (tip of the needle location) within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan
Liat Appelbaum, Dr.
Hadassah Ein Carem
Israel: Ministry of Health