Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients with sensorineural hearing loss
- Patients who will have cochlear implant surgery with CI422 electrode
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
Trial Site Locations
Total: 1 location
1
Pamukkale University
Denizli, Turkey (Türkiye), 20070
Actively Recruiting
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
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