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

NCT02892552 | Completed

• 1 other identifier: 2012.736
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• length of the intracochlear electrode array

  At inclusion

• percentage of implanted cochlea

  At inclusion

• number of intracochlear electrodes

  At inclusion

• radiation dose

  At inclusion

Study Arms (1)

Cone Beam

EXPERIMENTAL

Patients included will have first a MultiSlice Computed tomography (MSCT) as usual and then a Cone Beam Computed Tomography (CBCT)

Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Multiple Detector Computed Tomography (MDCT)

Interventions

Cone Beam Computed Tomography (CBCT) RADIATION

Patients had an additional Cone Beam Computed Tomography, after the usual MDCT

Cone Beam

Multiple Detector Computed Tomography (MDCT) RADIATION

Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography

Cone Beam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CI surgery for severe to profound bilateral deafness
• affiliated with the French health insurance

You may not qualify if:

• pregnancy
• Patients weighing more than 160 kg

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service imagerie pavillon B, Hopital E. Herriot

Lyon, 69003, France

Location

Related Publications (1)

• 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.

  PMID: 27518208 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 28, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)