Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation
NCT ID: NCT02892552
Last Updated: 2019-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2013-03-31
2013-06-30
Brief Summary
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Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.
Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.
Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Cone Beam
Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)
Cone Beam Computed Tomography (CBCT)
Patients had an additional Cone Beam Computed Tomography, after the usual MDCT
Multiple Detector Computed Tomography (MDCT)
Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography
Interventions
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Cone Beam Computed Tomography (CBCT)
Patients had an additional Cone Beam Computed Tomography, after the usual MDCT
Multiple Detector Computed Tomography (MDCT)
Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography
Eligibility Criteria
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Inclusion Criteria
* affiliated with the French health insurance
Exclusion Criteria
* Patients weighing more than 160 kg
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service imagerie pavillon B, Hopital E. Herriot
Lyon, , France
Countries
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References
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Razafindranaly V, Truy E, Pialat JB, Martinon A, Bourhis M, Boublay N, Faure F, Ltaief-Boudrigua A. Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation. Otol Neurotol. 2016 Oct;37(9):1246-54. doi: 10.1097/MAO.0000000000001165.
Other Identifiers
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2012.736
Identifier Type: -
Identifier Source: org_study_id
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