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Completed

NCT Number: NCT02892552

Cone Beam CT Versus Multislice CT 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.

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Key information

Conditions

Cochlear Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service imagerie pavillon B, Hopital E. Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cone Beam Computed Tomography (CBCT)

Radiation

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

Multiple Detector Computed Tomography (MDCT)

Radiation

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

Primary outcomes

  1. Concordance between MDCT and CBCT for assessing the scalar position of the electrodes

    Time frame: At inclusion

    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).

Secondary outcomes

  1. length of the intracochlear electrode array

    Time frame: At inclusion

    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.

  2. percentage of implanted cochlea

    Time frame: At inclusion

    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.

  3. number of intracochlear electrodes

    Time frame: At inclusion

    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.

  4. radiation dose

    Time frame: At inclusion

    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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COCOBE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 8, 2016
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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