Using platelet-rich fibrin during cochlear implantation to reduce fibrosis
Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | Pamukkale University Academic / other |
| Locations | 1 site (Denizli) |
| Trial ID | NCT05215197 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with sensorineural hearing loss who are scheduled for cochlear implant surgery using the CI422 electrode.
Not a fit: Patients with cochlear abnormalities or auditory neuropathy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Denizli
- Pamukkale University — Denizli, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Fazil N Ardic, MD
- Email: fnardic@pau.edu.tr
- Phone: 902582965799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.