Electromagnetic Tracking of Devices During Biopsy Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01403727|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : May 29, 2013
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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Electromagnetic Tracking of Devices During Biopsy Procedures|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||May 2013|
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.
- Radiation Dose [ Time Frame: 24 hrs ]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 ]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 ]Distance from defined target on PercuNav and angle of entry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403727
|United States, New York|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|Principal Investigator:||Edward Kim, MD||Icahn School of Medicine at Mount Sinai|