Electromagnetic Tracking of Devices During Interventional Procedures

Sponsor

Philips Healthcare (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01279148

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Biopsy or Ablation Procedures

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Electromagnetic Tracking of Devices During Interventional Procedures

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Target Registration Error [Day 1]
"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))

Secondary Outcome Measures

Success of ablation as determined by imaging [3 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Philips Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philips Healthcare

ClinicalTrials.gov Identifier:

NCT01279148

Other Study ID Numbers:

2010 MCT V7

First Posted:

Jan 19, 2011

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Keywords provided by Philips Healthcare

biopsy guidance

tracking device

Study Results

No Results Posted as of Apr 27, 2021