Electromagnetic Tracking of Devices During Biopsy Procedures
The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy in the areas of CT radiation dose, procedure time and biopsy accuracy.
This prospective, randomized, controlled trial will compare the use of electromagnetic tracking and image guidance (CT) during biopsy procedures verses the typical CT image guided procedure alone.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Electromagnetic Tracking of Devices During Biopsy Procedures|
- Radiation Dose [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]The primary objective of this study is to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.
- Total procedure time [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]Total procedure time is determined by the timespan of the moment the patient is accepted into the room (start) and the time when the procedure is complete (finish - when physician exits room).
- Accuracy of needle targeting [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]Distance from defined target on PercuNav and angle of entry
|Study Start Date:||November 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Unassisted Biopsy - CONTROL GROUP
Routine biopsy needle placement and Physician blinded to needle location
Assisted Biopsy - STUDY GROUP
The physician will be shown the PercuNav screen and will correct the desired approach path.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01403727
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Principal Investigator:||Edward Kim, MD||Mount Sinai School of Medicine|