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NCT01864291 · ClinicalTrials.gov registry record · NA
Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects
A NA study, sponsored by Massachusetts Eye and Ear Infirmary.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT01864291: Clinical Trial NA study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01864291 is a NA study that was terminated before completion, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01864291, a NA study, was terminated before completion, sponsored by Massachusetts Eye and Ear Infirmary.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in children who are deaf and cannot receive a cochlear implants.
Primary Outcome
We will track any major and minor complications peri-operatively and post-operatively in all study participants. Major complications include mortality, cerebellar contusion, facial palsy, meningitis, lower cranial neuropathy, hydrocephalus, pseudomeningocele and CSF leak. Minor complications include transient hydrocephalus, wound seroma, minor infections, balance problems, transient nerve palsies, transient dysphonia or difficulty swallowing, headache, flap problems, and non-auditory side effect
Interventions
- DEVICE Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2013-05 |
| Est. Completion | 2019-04-25 |
| Phase | NA |
Why NCT01864291 stopped before completion
NCT01864291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI) is the first listed.
NCT01864291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01864291 about?
NCT01864291 is a clinical study titled "Auditory Brainstem Implant (ABI) in Pediatric Non-Neurofibromatosis Type 2 Subjects". The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in children who are deaf and cannot receive a cochlear implants.
What is the current status of trial NCT01864291?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2013-05. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT01864291?
The interventions under investigation include: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI) (DEVICE).
Who is sponsoring clinical trial NCT01864291?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01864291's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 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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