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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ActiViews Ltd.
ClinicalTrials.gov Identifier:
NCT01367392
First received: June 6, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Accurate Navigation to the Lesion
 Device: biopsy or ablation
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by ActiViews Ltd.:

Primary Outcome Measures:
  • accuracy [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
    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:
  • time [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
    Total CT-Guided procedure time, starting with scan for entry point planning;

  • time [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
    Time required to guide the needle to the target

  • radiation [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
    Subject radiation exposure during the procedure

  • total number of scans [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
    Number of CT scans during the procedure


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367392

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

No publications provided

Responsible Party: ActiViews Ltd.
ClinicalTrials.gov Identifier: NCT01367392     History of Changes
Other Study ID Numbers: ACST-2011-1
Study First Received: June 6, 2011
Last Updated: February 14, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 16, 2013