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OpenTrials
Completed

NCT Number: NCT01367392

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.

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Key information

Conditions

Accurate Navigation to the Lesion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Victoria Hospital

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biopsy or ablation

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ActiViews Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 7, 2011
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.