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

Civil Hospices of Lyon

Status: Completed

Conditions: Cochlear Implants

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02892552

2012.736

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Cone Beam

Experimental group

Description:

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

Treatment:

Radiation: Multiple Detector Computed Tomography (MDCT)

Radiation: Cone Beam Computed Tomography (CBCT)