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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01401777 |
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Date of registration:
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21/07/2011 |
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Primary sponsor: |
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Public title:
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Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study
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Scientific title:
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Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01401777 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Cindy DiFrancesco, RN |
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Address:
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Telephone:
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216-445-9201 |
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Email:
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difranc@ccf.org |
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Affiliation:
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Key inclusion & exclusion criteria
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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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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Tumors
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Primary Outcome(s)
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Target Registration Error
[Time Frame: 24 hrs]
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Secondary Outcome(s)
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Accuracy of needle targeting
[Time Frame: 24 hrs]
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Secondary ID(s)
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2010_CRYO_V7
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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