Cochlear Implants Clinical Trial
Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation
Objective: To evaluate the diagnostic concordance between multislice computed tomography
(MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of
patients after cochlear implantation.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
|Source||Hospices Civils de Lyon|
|Start date||March 2013|
|Completion date||June 2013|
|Enrolling by invitation||