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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06424262




Registration number
NCT06424262
Ethics application status
Date submitted
16/05/2024
Date registered
22/05/2024
Date last updated
22/05/2024

Titles & IDs
Public title
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
Scientific title
A Pivotal, Prospective, Multi-centre, Randomised Controlled, Blinded Investigation Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.
Secondary ID [1] 0 0
CLTD5815
Universal Trial Number (UTN)
Trial acronym
DETECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Bilateral Sensorineural 0 0
Hearing Loss, Sensorineural 0 0
Hearing Loss, Bilateral 0 0
Hearing Loss, Cochlear 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CI622D
Treatment: Devices - CI622

Experimental: CI622D - Investigational Medical Device (IMD)

Active Comparator: CI622 - An approved medical device


Treatment: Devices: CI622D
A dexamethasone-eluting Slim Straight electrode

Treatment: Devices: CI622
A standard Slim Straight electrode
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean difference in the monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 3 months post-activation
Timepoint [1] 0 0
3 months post-activation
Secondary outcome [1] 0 0
Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622
Timepoint [1] 0 0
Throughout study (12 months)
Secondary outcome [2] 0 0
Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622
Timepoint [2] 0 0
Pre-operative, 0, 3, 6, 12 months post-activation
Secondary outcome [3] 0 0
Mean within-subject change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D
Timepoint [3] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [4] 0 0
Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D
Timepoint [4] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [5] 0 0
Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
Timepoint [5] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [6] 0 0
Difference in mean (within-subject) change in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
Timepoint [6] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [7] 0 0
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred unilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
Timepoint [7] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [8] 0 0
Difference in mean (within-subject) change in sentence recognition score in noise in the preferred bilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
Timepoint [8] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [9] 0 0
Difference in the mean four-point monopolar and nested bipolar trans-impedances and MP1+2 impedances between CI622D and CI622 measured intraoperatively and from activation to post-activation
Timepoint [9] 0 0
Intraoperative, 0, 3, 6, 12 months post-activation
Secondary outcome [10] 0 0
Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622
Timepoint [10] 0 0
0, 3, 6,12 months post-activation
Secondary outcome [11] 0 0
Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) from pre-implantation to post-activation between CI622D and CI622
Timepoint [11] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [12] 0 0
Difference in mean within-subject changes in global Health Utilities Index III (HUI3) from pre-implantation to post-activation between CI622D and CI622
Timepoint [12] 0 0
Pre-implantation, 3, 6, 12 months post-activation

Eligibility
Key inclusion criteria
- Aged 18 years or older (at time of consent)

- Clinically established post-linguistic bilateral moderately severe to profound
sensorineural hearing loss

- Meets local candidacy criteria for cochlear implantation

- Compromised functional hearing with a hearing aid in the ear to be implanted

- Willing to participate in and comply with all requirements of the protocol, including
willingness to be randomised to either arm

- Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines
prior to randomisation

- Candidate is proficient in the language used to assess speech perception performance

- Willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planned for a partial insertion of the electrode array

- Deafness due to lesions of the acoustic nerve or central auditory pathway, affecting
either ear

- Active middle-ear infection, in the ear to be implanted

- Active autoimmune disease, active immunosuppressive therapy, or use of anticoagulants
that cannot be discontinued for surgery

- Surgery (including grommets), drainage, presence of an unhealed tympanic membrane,
pain, or need for oral or topical antibiotics within 6 months prior to randomisation,
in the ear to be implanted

- Previously reported diagnosis of auditory neuropathy, in either ear

- Previously reported diagnosis, in either ear, of Large Vestibular Aqueduct Syndrome
(LVAS), Meniere's disease, or cochlear hydrops

- Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common
cavity, that might prevent complete insertion of the electrode array, as confirmed by
imaging, in the ear to be implanted

- Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula,
temporo-parietal skull fracture or CSF leaks

- History of bacterial meningitis

- Known allergic reaction or contraindication to dexamethasone or corticosteroids

- Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as
reported by the subject

- Severe, or poorer, sensorineural hearing loss of more than 20 years, as reported by
the subject, in the ear to be implanted

- Prior cochlear implantation, in either ear

- Medical plan for cochlear implantation during the clinical investigation,
contralateral to the ear to be implanted

- Medical or psychological conditions that contraindicate general anaesthesia, surgery
or participation in the clinical investigation

- Women who are pregnant or breastfeeding or plan to become pregnant during the
investigation

- Unrealistic expectations on the part of the subject, regarding the possible benefits,
risks, and limitations that are inherent to the surgical procedure(s) and prosthetic
devices as determined by the Investigator

- Additional disabilities that may affect the subject's participation or safety during
the clinical investigation, as determined by the Investigator

- Unable or unwilling to comply with the requirements of the clinical investigation as
determined by the Investigator

- Investigator site personnel directly affiliated with this study and/or their immediate
families; immediate family is defined as spouse, parent, child, or sibling to the
study candidate

- Cochlear employees or employees of Contract Research Organisations or contractors
engaged by Cochlear for the purposes of this investigation

- Current participation, or participation in another interventional clinical study/trial
in the past 30 days, involving an investigational drug or device (unless the other
investigation was/is a Cochlear sponsored investigation and determined by the
Investigator or Sponsor to not impact this investigation)

- Subjects recruited at a French site who are not affiliated with social security

- Subjects recruited at a French site who are under legal protection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Victorian Eye and Ear Hospital - Melbourne E.
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Melbourne E.
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Lille
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
France
State/province [3] 0 0
Toulouse
Country [4] 0 0
Germany
State/province [4] 0 0
Freiburg Im Breisgau
Country [5] 0 0
Germany
State/province [5] 0 0
Niedersachsen
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Manchester
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
QbD Clinical
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Avania
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical study will test a newly developed cochlear implant known as CI622D. This
experimental cochlear implant has been designed to slowly release a drug called
dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical
procedure. The goal is to learn if there are added benefits in implant performance and
hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard
cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with
sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or
auditory nerve. The study participants will undergo a series of tests that include testing
their implant and their hearing. They will also complete questionnaires to see how they rate
their hearing ability and their overall general health.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06424262
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antje Aschendorff
Address 0 0
Universitätsklinikum Freiburg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cherith Campbell-Bell
Address 0 0
Country 0 0
Phone 0 0
+6129428 6555
Fax 0 0
Email 0 0
ccampbellbell@cochlear.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06424262