Hearing Loss, SensorineuralNCT05215197
Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
A study testing intracochlear platelet rich fibrin administration in people with Hearing Loss, Sensorineural, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- intracochlear platelet rich fibrin administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2022to 20 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with sensorineural hearing loss
- Patients who will have cochlear implant surgery with CI422 electrode
Who cannot join
- Patients with cochlear abnormality
- Patients with auditory neuropathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, 20070
Fazil N Ardic, MD, +902582965799, fnardic@pau.edu.tr
About this study
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.
Read the 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.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- intracochlear platelet rich fibrin administration
- Keywords
- cochlear implant, platelet rich fibrin
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracochlear platelet rich fibrin administrationDrug
intracochlear platelet rich fibrin administration during routine cochlear implantation surgery
| Study group | Role | What they receive |
|---|---|---|
| intracochlear prf administration group | Experimental | intracochlear prf administration group Receives: Drug: intracochlear platelet rich fibrin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-6 months
Secondary outcomes (1)
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
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start31 Jan 2022
- Primary completion1 Dec 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open uncontrolled
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fazıl Necdet Ardıç, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215197
- Sponsor's protocol ID
- 11
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The metadata will be shared by a public depository.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05215197
- Acronym / sponsor ID
- 11
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- cochlear implant, platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open uncontrolled
| Arm | Type | Receives |
|---|---|---|
| intracochlear prf administration group | Experimental | Drug: intracochlear platelet rich fibrin administrationintracochlear prf administration group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with sensorineural hearing loss
- Patients who will have cochlear implant surgery with CI422 electrode
Key exclusion criteria (2 listed)
- Patients with cochlear abnormality
- Patients with auditory neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracochlear platelet rich fibrin administrationintracochlear platelet rich fibrin administration during routine cochlear implantation surgery | Drug | intracochlear prf administration group |
Primary outcome
Electrode Impedance(Ohm)
Time frame: 1-6 months
All intra-operative impedance values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months
1 secondary outcome
Electrode thresholds(CL)
Time frame: 1-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. The metadata will be shared by a public depository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracochlear platelet rich fibrin administration in people with Hearing Loss, Sensorineural, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fazil N Ardic, MD (902582965799, fnardic@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrode Impedance(Ohm) (time frame: 1-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.