A Study to Evaluate the Effectiveness of a Dexamethasone Eluting Slim Modiolar Electrode in the Reduction of Fibrosis in a Newly Implanted Adult Population with Bilateral, Post-Linguistic, Moderate to Profound Sensorineural Hearing Loss
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-001708
NCT ID: NCT04750642
Sponsor Protocol Number: CIP Number: CLTD5759
About this study
The purpose of this study is show the effectiveness of a dexamethasone eluting electrode in an adult population with post-lingual, bilateral, moderate to profound sensorineural hearing loss in the reduction of fibrosis (as measured by impedance) when compared to a conventional, non-dexamethasone eluting electrode and in the improvement of speech recognition from preoperative baseline.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss
at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a
pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
- 18 years or older at time of consent.
Exclusion Criteria:
- Abnormal cochlear and middle ear anatomy
- History with cochlear implant surgery
- Allergy to dexamethasone
- Women who are pregnant or plan to become pregnant
- Unable/unwilling to comply to study requirements
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 10/20/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aniket Saoji, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available