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NCT03858647 · ClinicalTrials.gov registry record
Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode
A clinical trial, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- 16
- Enrollment target
NCT03858647: Clinical Trial study, sponsored by Vanderbilt University Medical Center.
NCT03858647 is a clinical trial that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858647 was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- 16 participants
- Enrollment target
Study Summary
The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries. 2. To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes. 3. To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1. 4. To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire. 5. To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.
Primary Outcome
Audiologic speech performance as measured by CNC word recognition. CNC word tests consist of a 50 word list. Subjects repeat as much of each word as possible. Word scores will be calculated as percent correct at baseline through 24 months and reported as percentage points improved.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2021-12-31 |
Why NCT03858647 stopped before completion
NCT03858647 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03858647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03858647 about?
NCT03858647 is a clinical study titled "Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode". The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. To measure implant audiologic performance as defined by speech performa...
What is the current status of trial NCT03858647?
This trial is currently terminated. The enrollment target is 16 participants. The study started on 2019-02-21. Estimated completion is 2021-12-31.
Who is sponsoring clinical trial NCT03858647?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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