NCT01279148

Electromagnetic Tracking of Devices During Interventional Procedures

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biopsy or Ablation Procedures

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-01-19
• Last updated: 2021-04-27

Locations

1 site across 1 country: United States