Intracochlear Platelet-rich Fibrin Application in Cochlea... | NCT05215197

Studies
Intracochlear Platelet-rich Fibrin Application in Cochlear Implantation

NCT05215197

Sponsor

Pamukkale University

Status

Recruiting

Last Update Posted

Dec 27, 2024Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Hearing Loss, Sensorineural

Interventions

intracochlear platelet rich fibrin administration

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2022Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 20, 2025Estimated

First Submitted Date

Jan 18, 2022

First Submission Date that Met QC Criteria

Jan 18, 2022

First Posted Date

Jan 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2024

Last Update Posted Date

Dec 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fazıl Necdet Ardıç, Head of Department of Otolaryngology, Pamukkale UniversityPrincipal Investigator

Lead Sponsor

Pamukkale UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intracochlear prf administration group	Experimental	intracochlear prf administration group	Drug: intracochlear platelet rich fibrin administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intracochlear platelet rich fibrin administration	Drug	intracochlear platelet rich fibrin administration during routine cochlear implantation surgery	intracochlear prf administration group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	1-6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fazil N Ardic, MD	Contact	902582965799		fnardic@pau.edu.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University	Recruiting	Denizli		20070	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

The metadata will be shared by a public depository.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006319	Hearing Loss, Sensorineural

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

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Browse Branches

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