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

Cochlear Implants Clinical Trial

— COCOBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892552
• Other study ID #: 2012.736
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cochlear Implants

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