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The purpose of this study is to confirm the safety and effectiveness of the ActiSightâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional procedure | Experimental | The patients undergo the required interventional procedure, biopsy or ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy or ablation | Device | biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Montreal | Quebec | Canada |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 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 |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |