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

NCT02902497 | Completed

• 1 other identifier: 15-METHODO-01
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cochlear Implantation

Outcome Measures

Primary Outcomes (1)

• position of the cochleostomy

  at 1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

cadaver heads

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: September 15, 2016
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share