Using platelet-rich fibrin during cochlear implantation to reduce fibrosis
Official title: Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
Run by Pamukkale University · NCT05215197 · Data updated 2026-11-12
This study is testing whether using a special treatment called platelet-rich fibrin during cochlear implant surgery can help reduce scarring and improve how well the implants work over time.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Pamukkale University Academic / other |
| Locations | 1 site (Denizli) |
| Status | Recruiting |
| Started | January 31, 2022 |
| Main results expected | December 1, 2028 |
| Study ends | December 20, 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT05215197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with sensorineural hearing loss who are scheduled for cochlear implant surgery using the CI422 electrode.
✕Probably not a fit
Patients with cochlear abnormalities or auditory neuropathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the application of autologous platelet-rich fibrin during cochlear implantation to mitigate fibrosis, which often limits the effectiveness of cochlear implants. The procedure involves applying the fibrin to the round window of the cochlea during surgery, followed by the implantation of the device. The study will monitor intraoperative neural response telemetry (NRT) and impedance measurements at various postoperative intervals to assess the impact of the treatment on implant functionality. The goal is to enhance the long-term performance of cochlear implants by reducing inflammation and fibrosis.
Why it matters
Potential benefit: If successful, this approach could significantly improve the effectiveness and longevity of cochlear implants for patients with sensorineural hearing loss.
How similar studies have gone: While the application of platelet-rich fibrin in surgical procedures is gaining interest, this specific approach in cochlear implantation is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Pamukkale University
Denizli, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Fazil N Ardic, MD
- Email: fnardic@pau.edu.tr
- Phone: 902582965799
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term hearing and speech outcomes after cochlear implants
This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.
-
Comparing domestic and imported hearing aids for age-related hearing loss
This study is testing whether hearing aids made in the U.S. work better than imported ones for older adults with age-related hearing loss.
-
Gene therapy for hearing loss caused by OTOF gene mutations
This study is testing a new gene therapy to see if it can help children with hearing loss caused by OTOF gene mutations hear better.
-
Using robotics and electrocochleography for cochlear implant surgery
This study is testing if using a robotic system during cochlear implant surgery can help improve outcomes for people with hearing loss.
-
Understanding listening effort in cochlear implant users
This study tests how much effort people with cochlear implants need to understand speech compared to those with normal hearing, using speech tests and measuring pupil size to see how hard they are working to listen.
-
Comparing experiences of over-the-counter and audiologist-fitted hearing aids
This study looks at how people with mild-to-moderate hearing loss feel about using over-the-counter hearing aids compared to those fitted by an audiologist to see which option works better for their hearing and quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.