CLTD5815 DETECT
Research type
Research Study
Full title
A pivotal, prospective, multi-centre, randomised control, 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.
IRAS ID
333576
Contact name
Tracey Newman
Contact email
Sponsor organisation
Cochlear Limited
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
DETECT is a study that will test a new type of cochlear implant known as CI622D (Cochlear™ Nucleus® cochlear implant with Slim Straight dexamethasone eluting electrode). 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. This drug may support better healing following surgery and, as such, allow the cochlear implant to work at its best.
The study will look to see if there are benefits of the CI622D cochlear implant by comparing it with a standard cochlear implant that does not release dexamethasone (known as CI622, Cochlear™ Nucleus® cochlear implant with Slim Straight electrode). Study participants will receive either the CI622D or the CI622 and will undergo hearing tests and complete questionnaires to find out how well each implant works and how well the person can hear. Study participants will have a 50% chance of receiving either the CI622D or the CI622 and once the study is completed, will be informed about which cochlear implant they received.
Comparing the findings from these tests will help answer if there are added benefits of the dexamethasone-releasing cochlear implant over the standard cochlear implant. Safety of both CI622D and CI622 will be monitored throughout the study.
The study will last for around 21 months and will involve the study participants to attend four clinic visits in the first 12 months after receiving the cochlear implant. 48 study participants will be enrolled in up to 10 sites in the United Kingdom, France, Germany and Australia.
REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0201
Date of REC Opinion
26 Apr 2024
REC opinion
Further Information Favourable Opinion