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Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Primary Purpose

Hearing Loss, Sensorineural

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

intracochlear platelet rich fibrin administration

About this trial

This is an interventional prevention trial for Hearing Loss, Sensorineural focused on measuring cochlear implant, platelet rich fibrin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intracochlear prf administration group

Arm Description

intracochlear prf administration group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05215197

First Posted

January 18, 2022

Last Updated

September 14, 2023

Sponsor

Pamukkale University

1. Study Identification

Unique Protocol Identification Number

NCT05215197

Brief Title

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Official Title

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 31, 2022 (Actual)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sensorineural

Keywords

cochlear implant, platelet rich fibrin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

open uncontrolled

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intracochlear prf administration group

Arm Type

Experimental

Arm Description

intracochlear prf administration group

Intervention Type

Drug

Intervention Name(s)

intracochlear platelet rich fibrin administration

Intervention Description

intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Primary Outcome Measure Information:

Title

Electrode Impedance(Ohm)

Description

All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months

Time Frame

1-6 months

Secondary Outcome Measure Information:

Title

Electrode thresholds(CL)

Description

All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months

Time Frame

1-6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fazil N Ardic, MD

Phone

902582965799

fnardic@pau.edu.tr

Facility Information:

Facility Name

Pamukkale University

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fazil N Ardic, MD

Phone

+902582965799

fnardic@pau.edu.tr

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The metadata will be shared by a public depository.

Learn more about this trial

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

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