Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study

The objective of this study is to assess and quantify any differences between assisted (using real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using pre-procedure CT scans or CT fluoroscopy with respect to: Primary Endpoint: • "TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan)) Secondary Endpoints * Accuracy of needle targeting - The vector of each needle insertion (The initial vector allows us to project the path to the pre-defined target. If the initial entry point is not ideal, the path to the target will need adjustment) Based on a two-sample t-test (significance level of 0.05, two-tailed), the study has 89% power to detect a difference of 2mm in accuracy between the two treatment groups (assuming a standard deviation of 1.9mm). * Measure time difference between assisted and unassisted procedure

Sex

All

Minimum age

18 Years

Maximum age

100 Years

Inclusion Criteria:

1. Has had a pre-operative CT/MRI scan performed and will be undergoing an ablation procedure of the kidney;
2. Is over the age of 18;
3. Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
4. Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

1\. Was precluded from an ablation procedure based on standard ablation exclusions; 2. Has an adhesive allergy (due to the application of active fiducials with adhesive backing); 3. Has a pacemaker or automatic implantable cardiac defibrillator; 4. Has a gross body weight above the procedural table limit (typically \> 170 kg); 5. Is pregnant

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