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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02892552
Other study ID # 2012.736
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date June 2013

Study information

Verified date August 2016
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- CI surgery for severe to profound bilateral deafness

- affiliated with the French health insurance

Exclusion Criteria:

- pregnancy

- Patients weighing more than 160 kg

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
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

Locations

Country Name City State
France Service imagerie pavillon B, Hopital E. Herriot Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Razafindranaly V, Truy E, Pialat JB, Martinon A, Bourhis M, Boublay N, Faure F, Ltaïef-Boudrigua A. Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation. Otol Neurotol. 2016 Oct;37(9): — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Concordance between MDCT and CBCT for assessing the scalar position of the electrodes Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance.
Each radiologist determined CI localization. The cochlear implant (CI) was considered within the scala tympani if it was in the most posterior scala on axial reconstructions passing through the cochlea (behind the osseous spiral lamina often seen).
At inclusion
Secondary length of the intracochlear electrode array Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance.
This measurement was performed in the oblique coronal plane of the cochlea.
At inclusion
Secondary percentage of implanted cochlea Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance.
This measurement was performed in the oblique coronal plane of the cochlea.
At inclusion
Secondary number of intracochlear electrodes Blinded images were analyzed in random order by 2 radiologists with several years of experience in temporal bone imaging. Each radiologist analyzed on the workstation the images of each patient twice at 4- to 8-week intervals. A consensus reading was performed by a third experienced radiologist in case of discordance.
This measurement was performed in the oblique coronal plane of the cochlea.
At inclusion
Secondary radiation dose Radiation dose was estimated using Computed Tomography Dose Index (CTDI, in Gy.cm) for each patient and scanner. These data are collected directly from the data sheet for each examination (also anonymised). At inclusion
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