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Completed

NCT Number: NCT03950375

Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. peroperative round window exposure

    Time frame: Day 0

    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)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Round Window Visibility Prediction From Preoperative Scanner in Cochlear Implantation: Literature Review and Radiologic Criteria Evaluation

Acronym: R-PO18155

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 15, 2019
Registry last updated
Jun 16, 2020

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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