NCT05215197

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

3.8 years

First QC Date

January 18, 2022

Last Update Submit

December 24, 2024

Conditions

Hearing Loss, Sensorineural

Keywords

cochlear implantplatelet rich fibrin

Outcome Measures

Primary Outcomes (1)

  • 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

    1-6 months

Secondary Outcomes (1)

  • Electrode thresholds(CL)

    1-6 months

Study Arms (1)

intracochlear prf administration group

EXPERIMENTAL

intracochlear prf administration group

Drug: intracochlear platelet rich fibrin administration

Interventions

intracochlear platelet rich fibrin administrationDRUG

intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

intracochlear prf administration group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with sensorineural hearing loss
  • Patients who will have cochlear implant surgery with CI422 electrode

You may not qualify if:

  • Patients with cochlear abnormality
  • Patients with auditory neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fazil N Ardic, MD

CONTACT

902582965799fnardic@pau.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: open uncontrolled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Otolaryngology

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

January 31, 2022

Primary Completion

December 1, 2025

Study Completion

December 20, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The metadata will be shared by a public depository.

Locations

TU(1)