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Clinical Trials/NL-OMON36764
NL-OMON36764
Completed
Phase 3

Bilateral cochlear implantation in children; a pragmatic randomised controlled trial - BiCI children

niversitair Medisch Centrum Utrecht0 sites45 target enrollmentTBD
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ConditionsDeafnessHearing loss10019243

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Deafness
Sponsor
niversitair Medisch Centrum Utrecht
Enrollment
45
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

  • •\- Cochlear implant candidacy, according to the current criteria
  • •\- Age \< 2 years
  • •\- Written informed consent by parents or guardians
  • •\- General health allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
  • •\- Patients covered by the Dutch health insurance

Exclusion Criteria

  • •\- General health not allowing general anaesthesia for the potential implantation of two cochlear implants during a single surgery.
  • •\- Abnormal cochlear anatomy in one or both ears.
  • •\- Chronic ear infection in one or both ears.
  • •\- Previous cochlear implant experience.
  • •\- Disability which could interfere with the completion of the tests.
  • •\- Deafness caused by meningitis, otosclerosis or Cogans syndrome.
  • •\- Severely visually impaired

Outcomes

Primary Outcomes

Not specified

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