Sensorineural Hearing Loss Clinical Trial
— EAR2OSOfficial title:
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Verified date | July 2019 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
Status | Completed |
Enrollment | 3 |
Est. completion date | June 1, 2019 |
Est. primary completion date | April 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients suffering from profound sensorineural deafness requiring a Cochlear implant Exclusion Criteria: - Age under 18 years - Pregnant women - Anatomical anomalies of temporal bone - Chronic otitis media with or without cholesteatoma |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Antwerp |
Lead Sponsor | Collaborator |
---|---|
Prof. Vedat Topsakal |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel. | Image data aquired during the procedure | ||
Secondary | Number of completed middle ear access | The procedure (day 0) | ||
Secondary | Number of completed inner ear access | The procedure (day 0) | ||
Secondary | Accuracy of the drilled trajectory | Image data aquired during the procedure | ||
Secondary | Sensitivity and specificity of facial nerve monitoring | The procedure (day 0) | ||
Secondary | Measurement of the insertion angle | Measurement of the insertion depth of the electrode into the Cochlea | Image data aquired during the procedure | |
Secondary | Number of tip fold-overs | The procedure (day 0) | ||
Secondary | Number of Scala deviations | The procedure (day 0) | ||
Secondary | Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection | day 0-30 | ||
Secondary | Time of procedure | The procedure (day 0) | ||
Secondary | Volume of tissue removed | Image data aquired during the procedure |
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