Electromagnetic Tracking of Devices During Interventional Procedures

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Philips Healthcare
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01279148
First received: January 10, 2011
Last updated: November 28, 2013
Last verified: November 2013

January 10, 2011
November 28, 2013
April 2014
January 2015   (final data collection date for primary outcome measure)
Target Registration Error [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))
Same as current
Complete list of historical versions of study NCT01279148 on ClinicalTrials.gov Archive Site
Success of ablation as determined by imaging [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Primary effectiveness (success of ablation in local tumor control or success of biopsy in diagnostic biopsy sample). Successful ablation equals complete tumor ablation with a 5mm-1cm margin of normal tissue (if possible; quantified by the lack of enhancement of intravenous contrast material at 3 month follow up CT).
Same as current
Not Provided
Not Provided
 
Electromagnetic Tracking of Devices During Interventional Procedures
Electromagnetic Tracking of Devices During Interventional Procedures

This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.

The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with "US" ultrasound or "CT" computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients.

Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Liver Biopsy analyzed as per standard of care

Probability Sample

Hospitals and Out-patient Clinics

Biopsy or Ablation Procedures
Not Provided
  • Biopsy/Ablation - CONTROL GROUP
    The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded by pushing the start button again.
  • Biopsy/Ablation - STUDY GROUP:
    The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. The physician will then be un-blinded and shown the PercuNav screen and will correct the desired approach path and another screen capture will be taken. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded. At the end of the procedure, and if clinically indicated, a verification "CT" computed tomography scan will be taken with the needle in place and, sent to the PercuNav. Radiation dosage, due to CT imaging, will also be recorded.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis;
  • Is over the age of 18;
  • Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
  • Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

  • Was precluded from a biopsy/ablation procedure based on standard exclusions;
  • Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
  • Has a pacemaker or automatic implantable cardiac defibrillator;
  • Has a gross body weight above the procedural table limit (typically > 170 kg);
  • Is pregnant
Both
18 Years and older
No
United States
 
NCT01279148
2010 MCT V7
No
Philips Healthcare
Philips Healthcare
Not Provided
Not Provided
Philips Healthcare
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP