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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05215197
Other study ID # 11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2022
Est. completion date December 20, 2024

Study information

Verified date September 2023
Source Pamukkale University
Contact Fazil N Ardic, MD
Phone 902582965799
Email fnardic@pau.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fibrosis due to surgical trauma is a common problem with cochlear implants. Fibrosis limits the effectiveness of implant and increases the power consumption. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade.


Description:

The most common problem with cochlear implants is that their effectiveness decreases over time and they are not functional enough mainly due to fibrosis. Our aim in this study is to benefit from the anti-inflammatory effects of autologous platelet-rich fibrin to reducing the fibrotic cascade. Cochlear implant application will be performed under general anesthesia. After the postauricular incision and mastoidectomy, posterior tympanotomy will find the middle ear and from there the round window, and platelet fibrin prepared with the i-prf technique will be locally applied to the round window during the operation, and then implantation will be performed. The points where the electrode enters the cochlea will be covered with fascia. Intraoperative NRT and impedances will be measured on all electrodes in all patients, and NRT and impedance measurements will be repeated in the 1st week, 1st month, 3rd and 6th months postoperatively. Custom Sound EP 5.0 (5.0.4.136) program provided by Cochlear company will be used for these measurements.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 20, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intracochlear platelet rich fibrin administration
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrode Impedance(Ohm) All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months 1-6 months
Secondary Electrode thresholds(CL) All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months 1-6 months
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