Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System

Study Overview
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Brief Summary
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The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations . The device used in this study is designed to assist the physician in guiding the needle towards the suspected area. This device does not change the procedure of liver biopsy or ablation. The only difference is that a small adhesive pad is placed on the skin and a miniature video camera is attached to the end of the needle. This camera does not enter the body.

Official Title
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Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System

Conditions
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Accurate Navigation to the Lesion

Intervention / Treatment
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* Device: biopsy or ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment. Subjects scheduled for clinically indicated CT guided percutaneous needle placements in the liver who meet the desired target population described above. Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures. Verified home address and phone number to facilitate study follow-up. Exclusion Criteria: Significant coagulopathy that cannot be adequately corrected. Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure. Pregnant or nursing female subjects.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional procedure<br>The patients undergo the required interventional procedure, biopsy or ablation | Device: biopsy or ablation<br>* biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy | Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images. | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time | Total CT-Guided procedure time, starting with scan for entry point planning; | during the procedure | 
| time | Time required to guide the needle to the target | during the procedure | 
| radiation | Subject radiation exposure during the procedure | during the procedure | 
| total number of scans | Number of CT scans during the procedure | during the procedure |