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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02892552

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cochlear Implants	Radiation: Cone Beam Computed Tomography (CBCT) Radiation: Multiple Detector Computed Tomography (MDCT)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cone Beam 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) 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

Arm

Intervention/Treatment

Experimental: Cone Beam

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)

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

Outcome Measures

Primary Outcome Measures

Concordance between MDCT and CBCT for assessing the scalar position of the electrodes [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 Outcome Measures

length of the intracochlear electrode array [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.
percentage of implanted cochlea [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.
number of intracochlear electrodes [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.
radiation dose [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service imagerie pavillon B, Hopital E. Herriot	Lyon		France	69003

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT02892552

Other Study ID Numbers:

2012.736

First Posted:

Sep 8, 2016

Last Update Posted:

May 28, 2019

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of May 28, 2019