Back to resultsCochlear Implant With Anti-Inflammatory Agent
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Contour Advance electrode with controlled dose of dexamethasone base
Contour Advance electrode
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring cochlear implants, Dexamethasone, combined device
Eligibility Criteria
Inclusion Criteria:
- Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
- Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
- Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)
Exclusion Criteria:
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
- Current use of grommets or evidence of tympanic membrane perforation
- Known allergic reaction to dexamethasone or similar medicine
- Diagnosis of Auditory Neuropathy
- Active middle ear infection or history of middle ear infection within past two years
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- Unwillingness or inability of the candidate to comply with all investigational requirements
- Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation
Sites / Locations
- The HEARing CRC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CA with dexamethasone base
Contour Advance
Arm Description
Contour Advance electrode with controlled dose of dexamethasone base
Standard Contour Advance electrode array
Outcomes
Primary Outcome Measures
Surgical feedback
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Safety of Combined Device
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Secondary Outcome Measures
Electrode impedance
Electrically evoked compound action potential (ECAP)
Full Information
NCT ID
NCT02905305
First Posted
September 14, 2016
Last Updated
July 2, 2021
Sponsor
The Hearing Cooperative Research Centre
Collaborators
Cochlear, Royal Victoria Eye and Ear Hospital, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital Melbourne, Westmead Hospital, New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT02905305
Brief Title
Cochlear Implant With Anti-Inflammatory Agent
Official Title
Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2013 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearing Cooperative Research Centre
Collaborators
Cochlear, Royal Victoria Eye and Ear Hospital, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital Melbourne, Westmead Hospital, New South Wales
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.
In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
cochlear implants, Dexamethasone, combined device
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CA with dexamethasone base
Arm Type
Experimental
Arm Description
Contour Advance electrode with controlled dose of dexamethasone base
Arm Title
Contour Advance
Arm Type
Active Comparator
Arm Description
Standard Contour Advance electrode array
Intervention Type
Device
Intervention Name(s)
Contour Advance electrode with controlled dose of dexamethasone base
Intervention Description
The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
Intervention Type
Device
Intervention Name(s)
Contour Advance electrode
Intervention Description
Standard Contour Advance electrode
Primary Outcome Measure Information:
Title
Surgical feedback
Description
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Time Frame
During surgery
Title
Safety of Combined Device
Description
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Time Frame
Monitoring over 24 months
Secondary Outcome Measure Information:
Title
Electrode impedance
Time Frame
Testing over 24 months
Title
Electrically evoked compound action potential (ECAP)
Time Frame
Testing over 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)
Exclusion Criteria:
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
Current use of grommets or evidence of tympanic membrane perforation
Known allergic reaction to dexamethasone or similar medicine
Diagnosis of Auditory Neuropathy
Active middle ear infection or history of middle ear infection within past two years
Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
Unwillingness or inability of the candidate to comply with all investigational requirements
Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation
Facility Information:
Facility Name
The HEARing CRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
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Cochlear Implant With Anti-Inflammatory Agent
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