Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study
Withdrawn before enrolling
Conditions studied: Kidney Tumors
In brief
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
Key facts
- Study ID
- NCT01401777
- Run by
- Philips Healthcare
- People needed
- 0
- Starts
- 2014-12-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2021-04-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has had a pre-operative CT/MRI scan performed and will be undergoing an ablation procedure of the kidney;
- 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 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
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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