Actively Recruiting

Phase Not Applicable
All Genders
ID05215197

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation for Sensorineural Hearing Loss

Led by Pamukkale University · Updated on 2024-12-27

10

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying sensorineural hearing loss in patients receiving cochlear implants. The study aims to reduce fibrosis, a common issue that decreases implant effectiveness over time and increases power use. This research evaluates the use of autologous platelet-rich fibrin for its anti-inflammatory effects to slow down the fibrotic process. During cochlear implant surgery under general anesthesia, platelet-rich fibrin prepared by the i-prf technique is applied locally to the round window of the middle ear. After making a postauricular incision and mastoidectomy to access the middle ear, the implant electrode is inserted, and the entry points are covered with fascia. The intervention involves administering platelet-rich fibrin during the routine implant procedure. Participants will have their electrode impedance and neural response telemetry measured during surgery and again at 1 week, 1 month, 3 months, and 6 months after surgery using the Custom Sound EP 5.0 program. These assessments monitor implant function and fibrosis effects. The total study monitoring lasts for six months post-operation.

CONDITIONS

Official Title

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with sensorineural hearing loss
  • Patients who will have cochlear implant surgery with CI422 electrode
Not Eligible

You will not qualify if you...

  • Patients with cochlear abnormality
  • Patients with auditory neuropathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Pamukkale University

Denizli, Turkey (Türkiye), 20070

Actively Recruiting

Loading map...

Research Team

F

Fazil N Ardic, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Similar Trials

Phase I/II Study of SENS-501 Injection in Children With Seve...

OTOF Gene Mutation

Actively Recruiting

2 locations

A Prospective Cohort Study on Cognitive Changes in Age-Relat...

Age-related Hearing Loss

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here