NCT01367392

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: ActiViews Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Accurate Navigation to the Lesion

Interventions

Type	Name	Description
DEVICE	biopsy or ablation	biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-06-07
• Last updated: 2012-02-15

Locations

1 site across 1 country: Canada