Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Sponsor

Pamukkale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05215197

Collaborator

(none)

Enrollment

Location

Arm

10.6

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Drug: intracochlear platelet rich fibrin administration	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

open uncontrolledopen uncontrolled

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

Actual Study Start Date :

Jan 31, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intracochlear prf administration group intracochlear prf administration group	Drug: intracochlear platelet rich fibrin administration intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Arm

Intervention/Treatment

Experimental: intracochlear prf administration group

intracochlear prf administration group

Drug: intracochlear platelet rich fibrin administration

intracochlear platelet rich fibrin administration during routine cochlear implantation surgery

Outcome Measures

Primary Outcome Measures

Electrode Impedance(Ohm) [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

Secondary Outcome Measures

Electrode thresholds(CL) [1-6 months]
All intra-operative threshold values will be acquired after surgery. They will be repeated in first week, 1, 3 and 6th months

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey	20070

Sponsors and Collaborators

Pamukkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fazıl Necdet Ardıç, Head of Department of Otolaryngology, Pamukkale University

ClinicalTrials.gov Identifier:

NCT05215197

Other Study ID Numbers:

First Posted:

Jan 31, 2022

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fazıl Necdet Ardıç, Head of Department of Otolaryngology, Pamukkale University

cochlear implant

platelet rich fibrin

Additional relevant MeSH terms:

Hearing Loss

Hearing Loss, Sensorineural

Study Results

No Results Posted as of Jun 15, 2022