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OpenTrials
Completed

NCT Number: NCT02902497

Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation

The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the cochleostomy location of an endaural approach (MINV) compared to the conventional posterior tympanotomy (MPT) approach. Since 2010, the investigators use in the ENT department of Nice a new surgical endaural approach to perform cochlear implantation. In the hands of an inexperienced surgeon, the position of the cochleostomy has not yet been studied in detail for this technique. This is a prospective study of 24 human heads. Straight electrode arrays were implanted by an inexperienced surgeon: on one side using MPT and on the other side using MINV.

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Key information

Conditions

Cochlear Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • cadaver heads
  • person had provided written consent to give their entire body to science

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. position of the cochleostomy

    Time frame: at 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2016
Registry last updated
Sep 15, 2016

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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