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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 is a clinical trial that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 16 participants.
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2021-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03858647
The ClinicalTrials.gov registry entry for NCT03858647 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT03858647 reports 0 study locations.
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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