Health TrialsbyHealthPanel

Clinical Trial to Compare Two Surgical Approaches to the Cochlea

ConditionsCochlear ImplantsHearing Loss, Sensorineural
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgical approach: cochleostomy or extended round window

    Procedure/Surgery

    Surgical placement of a cochlear implant electrode array

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CochleostomyActive comparator 1 intervention
Group B: extended Round WindowActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Residual hearing

The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow).

Time frame
3-months postoperatively

Secondary outcomes

1

ECochG thresholds after multiple surgery stages

ECochG thresholds with a promontory recording electrode after the following surgery stages: a) posterior tympanotomy (baseline), b) drilling for RW membrane exposure, c) completion of the approach to implantation (CO or eRW), d) sheath insertion, e) electrode array insertion, f) sheath withdrawal, and g) positioning of the electrode lead.

Time frame
Intraoperatively
2

Intracochlear electrode position

The position of electrode contacts relative to the modiolus and the angular insertion depth (AID), as assessed with pre- and post-operative CT-scan.

Time frame
3-months postoperatively

Other outcomes

Sponsors and contacts

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Radboud University Medical Center

Lead sponsor

GZA Ziekenhuizen Campus Sint-Augustinus

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator

Source ClinicalTrials.gov
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