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Kidney Tumors clinical trials

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NCT ID: NCT01401777 Withdrawn - Kidney Tumors Clinical Trials

Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study

Start date: December 2014
Phase:
Study type: Observational

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