Electromagnetic Tracking of Devices During Interventional Procedures

Biopsy or Ablation Procedures Clinical Trial

Official title:

Electromagnetic Tracking of Devices During Interventional Procedures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01279148
• Other study ID #: 2010 MCT V7
• Status: Withdrawn
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2021
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biopsy or Ablation Procedures

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Registration Error	"TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position ("CT" Computed Tomography confirmation scan))	Day 1
Secondary	Success of ablation as determined by imaging	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).	3 months