Electromagnetic Tracking of Devices During Biopsy Procedures
Completed
Conditions studied: Liver Tumors
In brief
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.
Key facts
- Study ID
- NCT01403727
- Run by
- Philips Healthcare
- People needed
- 50
- Starts
- 2011-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has had a pre-operative CT scan performed and will be undergoing a biopsy procedure of the liver;
- 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.
You may not qualify if…
- Was precluded from a biopsy 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 180lbs for women and 260lbs for men;
- Is pregnant
- A patient may be excluded after enrollment if any of the following criteria are met:
- The patient's health and/or safety become jeopardized for any reason making it unsafe to continue; 2. Technical errors and/or difficulties; 3. Any reasonable rationale put forth by the physician or investigator 4. Lost to follow up - In-evaluable data
Where it is running
- Mount Sinai Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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