Lung Diseases Clinical Trial
Official title:
Phase IV Study of the ActiSight Needle Guidance System Which Assist in Guiding a Rigid Interventional Instrument Percutaneously, to a Designated Point Within the Body by Means of CT Visualization
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
The ActiSight™ Needle Guidance System is an optical navigation system designed to assist
physicians performing percutaneous interventions under CT guidance. The system allows the
user to select an obstacle free path to a target lesion based on pre-procedure CT images,
and then provides real-time information for guiding the interventional tool towards the
target along the selected path.
The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle
and a reference pad attached to the skin to register the needle into the CT image space, and
thus, track the needle advance towards the target. CT scans are used as needed to verify the
location of the needle.
The primary objective of this study is to demonstrate the effectiveness of the ActiSight™
Needle Guidance System in assisting in CT-guided percutaneous procedures.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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