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NCT02902497 Clinical Trial

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

Cochlear Implantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02902497
Other study ID # 15-METHODO-01
Secondary ID
Status Completed
Phase N/A
First received August 12, 2016
Last updated September 14, 2016
Start date March 2014
Est. completion date June 2014

Study information
Verified date September 2016
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cadaver heads

- person had provided written consent to give their entire body to science

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Outcome
Type Measure Description Time frame Safety issue
Primary position of the cochleostomy at 1 day No
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