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

February 14, 2012 updated by: ActiViews Ltd.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time
Time Frame: during the procedure
Total CT-Guided procedure time, starting with scan for entry point planning;
during the procedure
time
Time Frame: during the procedure
Time required to guide the needle to the target
during the procedure
radiation
Time Frame: during the procedure
Subject radiation exposure during the procedure
during the procedure
total number of scans
Time Frame: during the procedure
Number of CT scans during the procedure
during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ACST-2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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