Electromagnetic Tracking of Devices During Interventional Procedures

Withdrawn

• Conditions: Biopsy or Ablation Procedures

• Registration Number: NCT01279148
• Lead Sponsor: Philips Healthcare

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.

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 Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Study Start: 2014-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States