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

NCT ID: NCT01367392

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

interventional procedure

The patients undergo the required interventional procedure, biopsy or ablation

Group Type: EXPERIMENTAL

biopsy or ablation

Intervention Type: DEVICE

biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system

Interventions

biopsy or ablation

biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ActiViews Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

ACST-2011-1

Identifier Type: -

Identifier Source: org_study_id