Status:
COMPLETED
Electromagnetic Tracking of Devices During Biopsy Procedures
Lead Sponsor:
Philips Healthcare
Conditions:
Liver Tumors
Eligibility:
All Genders
18+ years
Brief Summary
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, random...
Detailed Description
The purpose of the trial is to evaluate the differences between PercuNav assisted and unassisted biopsy. The primary objective of this study is to assess and quantify any differences between assisted ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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:
- 1\. 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
- \-
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01403727
Start Date
November 1 2011
End Date
May 1 2013
Last Update
May 29 2013
Active Locations (1)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029