NCT02892552

Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation

Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cochlear Implants

Interventions

Type	Name	Description
RADIATION	Cone Beam Computed Tomography (CBCT)	Patients had an additional Cone Beam Computed Tomography, after the usual MDCT
RADIATION	Multiple Detector Computed Tomography (MDCT)	Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2016-09-08
• Last updated: 2019-05-28

Locations

1 site across 1 country: France