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CompletedNCT03950375R-PO18155Updated Jun 16, 2020

Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

An observational study in Cochlear Implantation, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.

Read the detailed description

Whereas several surgical techniques exist to perform a cochlear implantation, the most used is the realization of mastoidectomy followed by posterior tympanotomy, in order to expose the round window, which finally permits to access to the cochlea. This procedure might be complicated with facial paresis, loss of residual hearing, because of anatomy relationships in this millimetric area.

CT scan of temporal bone is part of systematic preoperative assessment. Technological advances in radiology during the last decades now provide inframillimetric resolution. Thus, otologic surgeons wish they could anticipate round window exposure from these CT scan. This could decrease the procedure duration, complication occurrence, or improve surgical strategy.

Several studies proposed radiological criteria in this aim, from more or less complex measures in preoperative temporal bone CT scan. However, these diagnostic tests performances have not been assessed for most of them, or compared between them.

02

Conditions studied

  • Cochlear Implantation

Keywords

  • Sensorineural Hearing Loss
  • Round Window
  • ear surgery
  • Cochlear implantation
03

In context

Lead sponsor

CHU de Reims is the lead sponsor of 267 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cochlear implantation

Eligibility criteria

inclusion criteria :

  • patients undergoing cochlear implantation in Reims universitary hospital during the inclusion period
  • patients who agree to participate in the study
  • patients who had preoperative temporal bone CT scan

exclusion criteria : patients who have :

  • temporal bone malformation on temporal bone CT scan or MRI
  • chronic otitis media (except simple middle ear effusion)
  • middle ear surgery antecedent
  • cochlear implant in the context of a reimplantation
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • cochlear implantation

    "cochlear implantation" group : patients undergoing cochlear implantation between December 2018 and June 2019 in the ENT service of Reims universitary hospital.

06

What researchers measure

Primary outcomes

  1. peroperative round window exposure

    peroperative round window exposure evaluated according to St Thomas' Hospital classification: * visible (classes I and II) and not visible (class III) * easily visible (classes I and IIa) and not easily visible (class IIb and III)

    Time frame: Day 0

07

Study locations

1 site
  • Damien JOLLY
    Reims, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03950375
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
May 15, 2019
Start date
Dec 18, 2018
Primary completion
Apr 24, 2019
Completion
Apr 24, 2019
Last update
Jun 16, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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