Clinical Trials Directory

Trials / Completed

CompletedNCT04397354

Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Pamukkale University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
DRUGIntracochlear Dexamethasoneintracochlear injection of dexamethasone with cochlear implantation
DRUGIntratympanic Dexamethasoneintratympanic injection of dexamethasone with cochlear implantation
DRUGNo additional drugs(control Group)Control group: No drugs will be injected middle ear with cochlear implantation

Timeline

Start date
2020-03-02
Primary completion
2022-08-01
Completion
2022-09-20
First posted
2020-05-21
Last updated
2023-01-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04397354. Inclusion in this directory is not an endorsement.