CompletedNCT01367392Updated Feb 15, 2012

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

A Phase 4 interventional study of biopsy or ablation in Accurate Navigation to the Lesion, sponsored by ActiViews Ltd.. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-02-15.

Sponsored by ActiViews Ltd. · Phase 4 and Interventional

Phase: Phase 4
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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 studied

Accurate Navigation to the Lesion

In context

Lead sponsor

ActiViews Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: 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

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 design

Phase: Phase 4
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
interventional procedure
The patients undergo the required interventional procedure, biopsy or ablation
Device: biopsy or ablation

Interventions

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

What researchers measure

Primary outcomes

accuracy
Frequency of placing the needle at a location suitable for the planned intervention, as determined by the investigator reviewing the CT images.
Time frame: during the procedure

Secondary outcomes

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

Study locations

1 site

Royal Victoria Hospital
Montreal, Quebec, Canada

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01367392
Lead sponsor: ActiViews Ltd.
Responsible party: Sponsor
First posted: Jun 7, 2011
Start date: Jun 2011
Primary completion: Jan 2012
Completion: Jan 2012
Last update: Feb 15, 2012

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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