Status:
COMPLETED
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Sensorineural Hearing Loss, Bilateral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
Detailed Description
The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear imp...
Eligibility Criteria
Inclusion
- Subjects scheduled for CI surgery according to clinical routine
- Subjects who will receive a cochlear implant of the MED-EL portfolio
- Signed and dated informed consent form
Exclusion
- Lack of compliance with any inclusion criteria
- Age under 18 years
- Pregnancy
- Distance of the planned trajectory to the facial nerve is \< 0.4 mm as per screening CT scan
- Distance of the planned trajectory to the chorda tympani is \< 0.3 mm as per screening CT scan
- A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
- Individuals where image guidance or robotic procedures are not indicated
- Individuals who have known allergy to components of the cochlear implant
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04777565
Start Date
September 15 2021
End Date
January 1 2023
Last Update
February 21 2023
Active Locations (1)
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1
CHU Montpellier
Montpellier, France, 34295