Cochlear Implant With Anti-Inflammatory Agent

Hearing Loss Clinical Trial

Official title:

Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905305
• Other study ID #: CLTD 5495
• Status: Completed
• Phase: N/A
• Start date: September 10, 2013
• Est. completion date: March 15, 2018

Study information

• Verified date: July 2021
• Source: The Hearing Cooperative Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 15, 2018
• Est. primary completion date: November 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years

2. Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age

3. Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)

Exclusion Criteria:

1. 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

2. Current use of grommets or evidence of tympanic membrane perforation

3. Known allergic reaction to dexamethasone or similar medicine

4. Diagnosis of Auditory Neuropathy

5. Active middle ear infection or history of middle ear infection within past two years

6. 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

7. Unwillingness or inability of the candidate to comply with all investigational requirements

8. Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Contour Advance electrode with controlled dose of dexamethasone base
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.
• Contour Advance electrode
Standard Contour Advance electrode

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria

Sponsors (6)

Lead Sponsor	Collaborator
The Hearing Cooperative Research Centre	Cochlear, Royal Prince Alfred Hospital, Sydney, Australia, Royal Victoria Eye and Ear Hospital, St Vincent's Hospital Melbourne, Westmead Hospital, New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During surgery
Primary	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	Monitoring over 24 months
Secondary	Electrode impedance		Testing over 24 months
Secondary	Electrically evoked compound action potential (ECAP)		Testing over 24 months