NL-OMON54404
Recruiting
N/A
Cochlear implant receiver/stimulator fixation with and without drilling; a single blind randomized controlled study - COMFIT trial
niversitair Medisch Centrum Utrecht0 sites112 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cochlear implant surgical techniques
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 112
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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