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NCT03156465 · ClinicalTrials.gov registry record · NA
Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
A NA study of Child and Hearing Loss, Bilateral, sponsored by University of Iowa.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT03156465 is a NA study of Child and Hearing Loss, Bilateral that has completed, run by University of Iowa. The registered enrollment target is 11 participants, below the 270-participant average among 8 other Child trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03156465, a NA study of Child and Hearing Loss, Bilateral, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.
Conditions Studied
Interventions
- DEVICE Hybrid L24
Study Locations (2)
Iowa
- University of Iowa - Iowa City
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-09-15 |
| Est. Completion | 2022-11-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03156465
The ClinicalTrials.gov registry entry for NCT03156465 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 270-participant average among 8 other Child trials with a reported enrollment target (96% lower). The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Child appearing as the primary indexed condition, and to 1 intervention - of which Hybrid L24 is the first listed.
NCT03156465 reports 2 study locations spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT03156465 about?
NCT03156465 is a clinical study titled "Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants". The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the ...
What is the current status of trial NCT03156465?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2011-09-15. Estimated completion is 2022-11-03.
What conditions does trial NCT03156465 study?
This clinical trial studies the following conditions: Child, Hearing Loss, Bilateral, Implants, Cochlear.
What interventions are being tested in trial NCT03156465?
The interventions under investigation include: Hybrid L24 (DEVICE).
Who is sponsoring clinical trial NCT03156465?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03156465 being conducted?
This trial has 2 study locations across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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