Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

NCT ID: NCT04397354

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-02

Study Completion Date

2022-09-20

Brief Summary

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The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods.

Detailed Description

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The protection of cochlear cells is one of the main concerns of cochlear implant surgery. New electrode designs or additional molecules have been used for this purpose. The aim of the study is to test the effect of dexamethasone in two different application methods. Participants who will have cochlear implant surgery will be divided into three groups. Group 1 will have intracochlear dexamethasone after the incision of the round window membrane. Group 2 will have intratympanic dexamethasone after the incision of the round window membrane. Group 3 will serve as a control group. All participants will be tested after a week, a month, 3, and 6 months. Impedance and threshold measurements will be compared.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

intracochlear dexamethasone application during cochlear implantation

Group Type ACTIVE_COMPARATOR

Intracochlear Dexamethasone

Intervention Type DRUG

intracochlear injection of dexamethasone with cochlear implantation

Group 2

intratympanic dexamethasone application during cochlear implantation

Group Type ACTIVE_COMPARATOR

Intratympanic Dexamethasone

Intervention Type DRUG

intratympanic injection of dexamethasone with cochlear implantation

Group 3

No drugs during cochlear implantation

Group Type SHAM_COMPARATOR

No additional drugs(control Group)

Intervention Type DRUG

Control group: No drugs will be injected middle ear with cochlear implantation

Interventions

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Intracochlear Dexamethasone

intracochlear injection of dexamethasone with cochlear implantation

Intervention Type DRUG

Intratympanic Dexamethasone

intratympanic injection of dexamethasone with cochlear implantation

Intervention Type DRUG

No additional drugs(control Group)

Control group: No drugs will be injected middle ear with cochlear implantation

Intervention Type DRUG

Other Intervention Names

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intracochlear intratympanic No drugs

Eligibility Criteria

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Inclusion Criteria

* Patients with sensorineural hearing loss
* Patients who will have cochlear implant surgery with CI422 electrode

Exclusion Criteria

* Patients with cochlear abnormality
* Patients with auditory neuropathy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Fazıl Necdet Ardıç

Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fazil N Ardic, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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