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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01367392
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
ActiViews Ltd.

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.

Condition or disease Intervention/treatment Phase
Accurate Navigation to the Lesion Device: biopsy or ablation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Confirmation of Clinical Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: interventional procedure
The patients undergo the required interventional procedure, biopsy or ablation
Device: biopsy or ablation
biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system

Primary Outcome Measures :
  1. accuracy [ Time Frame: during the procedure ]
    Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images.

Secondary Outcome Measures :
  1. time [ Time Frame: during the procedure ]
    Total CT-Guided procedure time, starting with scan for entry point planning;

  2. time [ Time Frame: during the procedure ]
    Time required to guide the needle to the target

  3. radiation [ Time Frame: during the procedure ]
    Subject radiation exposure during the procedure

  4. total number of scans [ Time Frame: during the procedure ]
    Number of CT scans during the procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01367392

Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada
Sponsors and Collaborators
ActiViews Ltd.

Responsible Party: ActiViews Ltd. Identifier: NCT01367392     History of Changes
Other Study ID Numbers: ACST-2011-1
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012