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NCT01904448 · ClinicalTrials.gov registry record · NA
Auditory Brainstem Implantation in Young Children
A NA study of Developmental Cochlear Nerve Deficiency and Acquired Cochlear Nerve Deficiency, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT01904448: Completed NA study of Developmental Cochlear Nerve Deficiency and Acquired Cochlear Nerve Deficiency, sponsored by University of North Carolina, Chapel Hill.
NCT01904448 is a NA study of Developmental Cochlear Nerve Deficiency and Acquired Cochlear Nerve Deficiency that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904448, a NA study of Developmental Cochlear Nerve Deficiency and Acquired Cochlear Nerve Deficiency, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (CI) or have been unable to receive a CI secondary to cochlear or cochlear nerve disorders. These conditions can include: developmental or acquired cochlear nerve deficiency (CND), cochlear aplasia (Michel), post-meningitic cochlear ossification or cochlear malformation. This study proposes to implant up to 10 young children (\<5 yrs. of age) with the Nucleus 24 Multichannel ABI (Sydney, AUS) in an attempt to demonstrate safety of the surgical procedure, tolerance of device stimulation, and the potential for auditory benefit beyond that experienced with their CI. This study will provide the preliminary experience for a larger scale clinical trial. Aim 1: Demonstrate the safety of ABI surgery in children. Aim 2: Demonstrate the development of sound awareness and improved speech understanding among children implanted with the ABI when compared to their baseline skills. Aim 3: Demonstrate the development of oral language skills following the use of the ABI that were not evident prior to its use.
Primary Outcome
Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.
Conditions Studied
Interventions
- DEVICE Auditory Brainstem Implantation in Children
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-10-01 |
| Phase | NA |
What the finished NCT01904448 record still lists
NCT01904448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Developmental Cochlear Nerve Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Auditory Brainstem Implantation in Children is the first listed.
NCT01904448 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01904448 about?
NCT01904448 is a clinical study titled "Auditory Brainstem Implantation in Young Children". To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis type II (NFII) that have either experienced failed cochlear implantation (...
What is the current status of trial NCT01904448?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2012-09. Estimated completion is 2017-10-01.
What conditions does trial NCT01904448 study?
This clinical trial studies the following conditions: Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification, Cochlear Malformation.
What interventions are being tested in trial NCT01904448?
The interventions under investigation include: Auditory Brainstem Implantation in Children (DEVICE).
Who is sponsoring clinical trial NCT01904448?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904448 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01904448's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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