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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06642935




Registration number
NCT06642935
Ethics application status
Date submitted
13/10/2024
Date registered
15/10/2024

Titles & IDs
Public title
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults with Severe Hearing Loss
Scientific title
A Feasibility, Interventional, Prospective Study to Enhance Features and Optimise the Clinical Pathway for the TICI Research System in Adult Cochlear Implant Recipients
Secondary ID [1] 0 0
AI5848
Secondary ID [2] 0 0
AI5848
Universal Trial Number (UTN)
Trial acronym
ENHANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Bilateral or Unilateral 0 0
Hearing Loss, Sensorineural 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 - Totally implantable cochlear Implant

Experimental: Device :TICI G2 Clinical Investigation System - Totally implantable cochlear Implant


Treatment: Devices: Totally implantable cochlear Implant
Totally implantable cochlear Implant
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in the cochlear implant internal microphone frequency gain response over time
Timepoint [1] 0 0
1 day, 7 days, 14 days, 21 days, 8 weeks (60 days), 12 weeks (90 days), 52 weeks (12 months) and 77 weeks (18 months) post-implantation surgery

Eligibility
Key inclusion criteria
* Aged 18 years or older, at time of consent
* Candidate for cochlear implantation as assessed by the implanting clinic
* Fluent in English, as determined by the investigator
* Willing to participate in and comply with all requirements of the protocol
* 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
* Severe, or poorer, bilateral sensorineural hearing loss prior to five years of age, as reported by the subject
* Duration of severe to profound hearing loss greater than 20 years in the ear to be implanted as reported by the subject or by audiometric history, if available
* Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array
* Deafness due to lesions of the acoustic nerve affecting the ear to be implanted
* Medical or psychological conditions that would contraindicate undergoing anaesthesia, surgery or participation in the clinical investigation, 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
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device, as determined by the investigator
* Desire to use an integrated acoustic component post-implantation
* 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 a spouse, parent, child, or sibling
* Cochlear employees or employees of Contract Research Organizations 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
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
18/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Victoria Eye and Ear Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michelle Moran
Address 0 0
Cochlear Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Niva Shrestha Clinical Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 2 9428 6555
Fax 0 0
Email 0 0
nshrestha@cochlear.com
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/NCT06642935