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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06424262
Ethics application status
Date submitted
16/05/2024
Date registered
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, 6-month Blinded Investigation Followed by a 6-month Open-label Phase 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 6 months post-activation
Timepoint [1] 0 0
6 months post-activation
Secondary outcome [1] 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 [1] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [2] 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 [2] 0 0
Throughout study (12 months)
Secondary outcome [3] 0 0
Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622
Timepoint [3] 0 0
Pre-operative, 0, 3, 6, 12 months post-activation
Secondary outcome [4] 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 [4] 0 0
Pre-implantation, 3, 6, 12 months post-activation
Secondary outcome [5] 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 [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 nested bipolar 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
* Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
* Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
* Active autoimmune disease or active immunosuppressive therapy
* Any of the following in the ear to be implanted within 3 months prior to enrolment: history of prior otologic surgery including grommets, or tympanic membrane perforation
* Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
* Previously reported diagnosis, in the ear to be implanted, 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, as determined by the investigator
* Women who are pregnant
* 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 Cochlear sponsored and determined by 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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2024
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06424262