Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures

Study Overview
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Brief Summary
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To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Diseases, Liver Diseases

Intervention / Treatment
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* Device: ActiSight Needle Guidance System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, 18 years of age or older at the time of enrollment. Subjects meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion. Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures. Exclusion Criteria: Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician. Significant coagulopathy that cannot be adequately corrected. Patients who have a medical contraindication to sedation (Lidocaine allergy). Pregnancy or lactation. Participation in an investigational trial within 30 days of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActiSight Needle Guidance System<br> | Device: ActiSight Needle Guidance System<br>* 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.<br>* Other names: ASNG=ActiSight Needle Guidance System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion |  | 1 Hour- During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time (needle dwell time in the body) |  | 1 hour -duration of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thorax, abdomen