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NCT03858647
Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode
trial in Sensorineural Hearing Loss in 16 participants. Terminated before completion.
31 December 2021
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 16 |
| Start date | 21 February 2019 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across United States |
Conditions studied
- Sensorineural Hearing Loss — all drugs for Sensorineural Hearing Loss →
Sponsor
Vanderbilt University Medical Center
Who can join
18 and older, any sex, with Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03858647
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03858647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 2 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03858647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing