Cochlear implant receiver/stimulator fixation with and without drilling; a single blind randomized controlled study
- Conditions
- cochlear implant surgical techniques1001924310019190
- Registration Number
- NL-OMON54404
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 112
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• The patient has provided written informed consent authorization before
participating in the study.
• The patient is >=18 years of age at the time of consent.
• The patient is a primary cochlear implantation candidate according to all
standard care criteria.
• The patient has Dutch written language proficiency.
• The patient is physically able to undergo a CBCT scan.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Revision surgery
• Re-implantation
• Other applied techniques than mentioned in the materials and methods
• Inability to understand or sign informed consent
• Pregnancy during the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint: Migration of the R/S device, measured in millimetres and<br /><br>degrees.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- COMPASS questionnaire scores<br /><br>- Electrode array migration<br /><br>- Electrode impedance values<br /><br>- Audiological results (cvc wordtest score)<br /><br>- Complication rates</p><br>