Biopsy Clinical Trial
Official title:
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 Chest Aspiration and Biopsy
This study is designed to evaluate preliminary safety and accuracy of the ActiSightâ„¢ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.
Why is this study conducted to demonstrate the safety and effectiveness of the ActiSight
Needle Guidance System in assisting trained physicians perform CT guided percutaneous needle
biopsy (PNB) and fine needle aspiration (FNA) procedures in the chest.
Subjects, who are scheduled for medically indicated chest PNB or FNA procedures and meet all
the inclusion and exclusion criteria, will be asked to participate in the study. The aim is
to enroll 40 subjects that will complete the whole study.
Recruited subjects will go through screening tests and if eligible, will undergo, within 18
days of screening, CT Guided chest PNB or FNA utilizing the ActiSight Needle Guidance
system. Subjects will be observed and tested for at least an hour after the procedure to
detect any serious complications. A follow-up will be conducted within 7-10 days after the
procedure day for safety evaluations. Safety and accuracy data from all stages of the study
will be collected and analyzed.
The effectiveness of the guidance system will be measured primarily by the frequency of
reaching the intended targets, as determined by a final CT scan. Other measures will include
the number of needle punctures and the number of intermediate CT scans needed to complete
the procedure. The safety of the system will be measured by the frequency and severity of
adverse events.
Procedure description:
First, a single-use, disposable pad (ActiSticker) is attached to the patient's skin over the
point of needle insertion as selected by the interventionist. The pad incorporates reference
objects that are easily detectable both on CT images and visually. A volume CT scan,
covering at least the pad, the target lesion and adjacent structures is then performed.
Next, the CT images from the volume scan are transferred to the ActiSight computer where the
operator marks the target of the procedure, as well as all the reference points on the
ActiSticker. Next, an optical sensor, also single-use and disposable, is attached to the top
of the needle. By optically detecting all the reference points and relating them to their
known positions on the CT images, the system can calculate the position of the top and the
tip of the needle with relation to the target lesion. During the procedure, the system shows
the user, on a graphic computer display, whether the needle is aimed directly at the target
and how far the tip of the needle is from the intended target to help the user aim the
insertion and guidance of the needle to the target.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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