Electromagnetic Tracking of Devices During Biopsy Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philips Healthcare
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Radiation Dose
Study Overview
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, 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.
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 and unassisted CT guided biopsy procedures of the liver with respect to radiation dose.
The secondary objectives of this study are to assess and quantify any differences between assisted and unassisted CT guided biopsy procedures with respect to:
- Total procedure time
- Accuracy of needle targeting (distance from defined target on PercuNav and angle of entry)
- Number of needle passes
- Target registration error (TRE- distance between "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan))
The study will consist of 50 patients from 1 site. The expected completion time for enrollment is 3 months, but will depend on the ability of the clinic to enroll patients. There are two arms in the study. An Unassisted Biopsy Control arm (physician and patient blinded to needle positioning using PercuNav system) and Assisted Biopsy (Physician not blinded to needle positioning using PercuNav). Patients will be randomized to each arm.
The PercuNav provides real-time, three-dimensional visualization and navigation tools for all stages of diagnosis and surgery including pre-procedure planning and intra-procedure navigation. PercuNav transforms two-dimensional patient images (scan sets), derived from CT, PET/CT and MRI into dynamic representations on which a tool can be navigated and fused with ultrasound. The system performs spatial mapping from one image space to another image space or from image space to physical space (registration) allowing the physician to correlate scan sets with each other and to the patient.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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;
- •Technical errors and/or difficulties;
- •Any reasonable rationale put forth by the physician or investigator
- •Lost to follow up - In-evaluable data
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Total procedure time(24 hrs)
- Accuracy of needle targeting(24 hrs)