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The trial is taking place at:
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Centre Hospitalier Universitaire de Lille | Claude Huriez Hospital - Gastroenterology Department

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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) (DETECT)

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Cochlear

Status

Not yet enrolling

Conditions

Hearing Loss, Bilateral Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Cochlear
Hearing Loss, Sensorineural

Treatments

Device: CI622D
Device: CI622

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT06424262
CLTD5815

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

CI622D
Experimental group
Description:
Investigational Medical Device (IMD)
Treatment:
Device: CI622D
CI622
Active Comparator group
Description:
An approved medical device
Treatment:
Device: CI622

Trial contacts and locations

9

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Central trial contact

Beatrice Reusens; Cherith Campbell-Bell

Data sourced from clinicaltrials.gov

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