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NCT02310399 · ClinicalTrials.gov registry record · NA
Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
A NA study of Hearing Loss, Bilateral (Causes Other Than Tumors), sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02310399: Recruiting NA study of Hearing Loss, Bilateral (Causes Other Than Tumors), sponsored by NYU Langone Health.
NCT02310399 is a NA study of Hearing Loss, Bilateral (Causes Other Than Tumors) that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02310399, a NA study of Hearing Loss, Bilateral (Causes Other Than Tumors), is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.
Primary Outcome
Study participants will be monitored on a case-by-case basis for ongoing or unanticipated medical complications. Adverse events will be tracked on a case-by-case basis and recorded at the time of occurrence and followed up at resolution. Any adverse events will be reported to the NYUSOM IRB. Should there be concern for the safety of the subjects because of their participation in the study by the investigators or the IRB, the study would be halted at least temporarily and a detailed discussion wi
Conditions Studied
Interventions
- DEVICE Nucleus ABI541 Auditory Brainstem Implant
Study Locations (1)
New York
- NYU Cochlear Implant Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-05 |
| Est. Completion | 2030-05 |
| Phase | NA |
What NCT02310399 shows while recruiting
NCT02310399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 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 1 condition, with Hearing Loss, Bilateral (Causes Other Than Tumors) appearing as the primary indexed condition, and to 1 intervention - of which Nucleus ABI541 Auditory Brainstem Implant is the first listed.
NCT02310399 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02310399 about?
NCT02310399 is a clinical study titled "Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves". This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with ...
What is the current status of trial NCT02310399?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2014-05. Estimated completion is 2030-05.
What conditions does trial NCT02310399 study?
This clinical trial studies the following conditions: Hearing Loss, Bilateral (Causes Other Than Tumors).
What interventions are being tested in trial NCT02310399?
The interventions under investigation include: Nucleus ABI541 Auditory Brainstem Implant (DEVICE).
Who is sponsoring clinical trial NCT02310399?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02310399 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss, Bilateral (Causes Other Than Tumors)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02310399's enrollment target sits among peer trials
20 1769th of 2000 higher than 140 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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