Status:
WITHDRAWN
Feasibility Study of Auditory Brainstem Implant in Young Children
Lead Sponsor:
House Research Institute
Collaborating Sponsors:
House Clinic, Inc.
Children's Hospital Los Angeles
Conditions:
Bilateral Cochlear Aplasia
Bilateral Cochlear Nerve Deficiency
Eligibility:
All Genders
2-5 years
Phase:
PHASE1
Brief Summary
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem...
Eligibility Criteria
Inclusion
- Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
- If previously received a cochlear implant, must demonstrate lack of benefit from that device
Exclusion
- Medical contraindication to craniotomy/intracranial surgery
- Severe cognitive or developmental delays
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01850225
Start Date
October 1 2013
End Date
September 1 2017
Last Update
March 18 2015
Active Locations (1)
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1
House Research Institute CARE Center
Los Angeles, California, United States, 90057