Clinical Trial to Compare Two Surgical Approaches to the Cochlea

NCT ID: NCT06453343

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-11-30

Brief Summary

This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.

Detailed Description

Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead.

Objective: The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging.

Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of <80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.

Conditions

Cochlear Implants; Hearing Loss, Sensorineural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cochleostomy

When employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane.

Group Type: ACTIVE_COMPARATOR

Surgical approach: cochleostomy or extended round window

Intervention Type: PROCEDURE

Surgical placement of a cochlear implant electrode array

extended Round Window

In case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy.

Group Type: ACTIVE_COMPARATOR

Surgical approach: cochleostomy or extended round window

Intervention Type: PROCEDURE

Surgical placement of a cochlear implant electrode array

Interventions

Surgical approach: cochleostomy or extended round window

Surgical placement of a cochlear implant electrode array

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
• CI candidate based on local or national reimbursement criteria.
• Cochlear implantation with a CI632.
• Preoperative 500 Hz pure-tone air conduction threshold <80 dB hearing level (HL) in the ear to be implanted.
• Willing and able to provide written informed consent.

Exclusion Criteria

• Previous or existing CI recipient.
• Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
• Abnormal cochlear nerve anatomy on preoperative CT or MRI.
• Subjects who are unable to undergo CT or MRI.
• Deafness due to acoustic nerve or central auditory pathway lesions.
• Diagnosis of auditory neuropathy.
• Active middle ear infection.
• Additional handicaps that would prevent participation in study evaluations.
• Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GZA Ziekenhuizen Campus Sint-Augustinus

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud University Medical Center

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Coby Lindeboom, MD

Role: CONTACT

Coby.lindeboom@radboudumc.nl

024 361 14934

Emmanuel Mylanus

Role: CONTACT

Emmanuel.Mylanus@radboudumc.nl

Facility Contacts

Lindeboom

Role: primary

Coby.lindeboom@radboudumc.nl

Other Identifiers

NL85808.091.23

Identifier Type: -

Identifier Source: org_study_id