Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607898373634 Date of Registration: 06/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mitigating Insertion Trauma in the Fibrotic Cochlea
Official scientific title A Randomized Trial Comparing Viscoelastic, Anti-Inflammatory, and Standard Approaches Across Multiple Electrode Arrays
Brief summary describing the background and objectives of the trial Cochlear implantation in patients with intracochlear fibrosis presents a significant clinical challenge. The presence of fibrous tissue increases friction and resistance during surgery, which directly elevates the risk of insertion trauma, scalar translocation, and subsequent damage to delicate residual cochlear structures. While various round window insertion techniques are used, optimizing the intracochlear environment during advancement is critical to reducing mechanical resistance and preserving neural pathways, particularly in pediatric patients under the age of 5. This randomized controlled trial aims to evaluate and compare the efficacy of three distinct intraoperative approaches—viscoelastic lubrication using Hyaluronic Acid, localized anti-inflammatory modulation using Dexamethasone, and standard saline irrigation. The primary objective is to determine which method most effectively mitigates insertion trauma by measuring optimal insertion forces and the total number of insertion trials required during the surgical procedure. Secondary objectives include evaluating immediate post-insertion electrophysiological impedance and verifying post-operative scalar preservation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MIT-FC
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 15/05/2026
Actual trial start date 15/05/2026
Anticipated date of last follow up 15/07/2026
Actual Last follow-up date 15/07/2026
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
KFSIRB200567 Kafrelsheikh University Hospital IRB
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hyaluronic Acid Active perfusion of the cochlea with 20 mg/2mL of Hyaluronic Acid prior to array insertion Single intraoperative administration prior to electrode array insertion Intracochlear administration of dexamethasone for localized anti-inflammatory modulation prior to array insertion via the round window approach 30
Experimental Group Dexamethasone Intracochlear administration of dexamethasone at 4 mg/mL Single intraoperative administration prior to electrode array insertion Intracochlear administration of dexamethasone for localized anti-inflammatory modulation prior to array insertion via the round window approach 30
Control Group Standard Saline Standard surgical protocol utilizing standard saline irrigation Single intraoperative administration prior to electrode array insertion Standard surgical protocol utilizing standard saline irrigation prior to array insertion via the round window approach 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pediatric patients strictly under the age of 5 years. A confirmed audiological diagnosis of severe-to-profound sensorineural hearing loss (SNHL), defined by a Pure Tone Average (PTA) exceeding 80 dB. Radiological or intraoperative confirmation of intracochlear fibrosis, specifically limited to Grades 1 and 2. Patients with no history of prior cochlear surgery or evidence of total cochlear ossification. Any presence of structural cochlear malformations, such as Mondini dysplasia, which would alter standard insertion mechanics. Diagnoses of syndromic hearing loss (e.g., Usher syndrome) to prevent phenotypic confounding. Infant: 1 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 1 Year(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/05/2026 Institutional Review Board of Kafrelsheikh University Hospital
Ethics Committee Address
Street address City Postal code Country
El-Geish Street, Kafrelsheikh University Campus Kafrelsheikh 33516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Optimal Insertion Force (Tactile and mechanical resistance encountered during electrode array advancement) Intraoperatively during the active phase of surgery
Primary Outcome Insertion Trials (Precise number of manual manipulations or retractions required to achieve full array insertion) Intraoperatively during the active phase of surgery
Secondary Outcome Electrophysiological Metrics (Baseline impedance values across active electrode channels) Immediately post-insertion
Secondary Outcome Scalar preservation and final anatomical array position verified via transorbital X-rays Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospital El-Geish Street, Kafrelsheikh University Campus Kafrelsheikh 33516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kafrelsheikh University El-Geish Street, Kafrelsheikh University Campus Kafrelsheikh 33516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kafrelsheikh University El-Geish Street, Kafrelsheikh University Campus Kafrelsheikh 33516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hussein El Shirbeny hassien.med_0127@med.kfs.edu.eg +201012788746 El-Geish Street, Kafrelsheikh University Campus
City Postal code Country Position/Affiliation
Kafrelsheikh 33516 Egypt Faculty of Medicine Kafrelsheikh University
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbdelMaboud MohamedAbdel-Maboud.6.206@azhar.edu.eg +201028324400 Al-Azhar University, Nasr City
City Postal code Country Position/Affiliation
Cairo 11884 Egypt Faculty of Medicine Al Azhar University
Role Name Email Phone Street address
Public Enquiries Mohamed AbdelMaboud MohamedAbdel-Maboud.6.206@azhar.edu.eg +201028324400 Al-Azhar University, Nasr City
City Postal code Country Position/Affiliation
Cairo 11884 Egypt Faculty of Medicine Al Azhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized individual participant data that underlie the results reported in the final publication (including text, tables, and figures) will be made available upon reasonable request to ensure academic transparency. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available beginning 6 months and ending 36 months following final publication of the study results. Data will be shared with researchers who provide a methodologically sound proposal approved by the institutional review board. Requests must be directed to the corresponding author's email.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 28/06/2026 Updated the brief summary section to include a detailed clinical background regarding intracochlear fibrosis and insertion trauma, as requested by the editorial review team to improve protocol clarity. This study evaluates ways to make cochlear implant surgery safer for children who have scarring (fibrosis) inside the inner ear. Scarring creates friction, increasing the risk of tissue damage during electrode array insertion. The trial compares three methods: injecting a lubricating gel (hyaluronic acid), using an anti-inflammatory medication (dexamethasone), or using regular saline. The objective is to evaluate the efficacy of Hyaluronic Acid in reducing insertion forces and preserving cochlear structures compared to dexamethasone and standard saline. Cochlear implantation in patients with intracochlear fibrosis presents a significant clinical challenge. The presence of fibrous tissue increases friction and resistance during surgery, which directly elevates the risk of insertion trauma, scalar translocation, and subsequent damage to delicate residual cochlear structures. While various round window insertion techniques are used, optimizing the intracochlear environment during advancement is critical to reducing mechanical resistance and preserving neural pathways, particularly in pediatric patients under the age of 5. This randomized controlled trial aims to evaluate and compare the efficacy of three distinct intraoperative approaches—viscoelastic lubrication using Hyaluronic Acid, localized anti-inflammatory modulation using Dexamethasone, and standard saline irrigation. The primary objective is to determine which method most effectively mitigates insertion trauma by measuring optimal insertion forces and the total number of insertion trials required during the surgical procedure. Secondary objectives include evaluating immediate post-insertion electrophysiological impedance and verifying post-operative scalar preservation.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/06/2026 as requested by the editorial review team Experimental Group, Hyaluronic Acid, Active perfusion of the cochlea with 20 mg/2mL of Hyaluronic Acid prior to array insertion, Single intraoperative administration prior to electrode array insertion, Intracochlear administration of dexamethasone for localized anti-inflammatory modulation prior to array insertion via the round window approach , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/06/2026 as requested by the editorial review team Experimental Group, Dexamethasone Group, Intracochlear administration of dexamethasone at 4 mg/mL , Single intraoperative administration prior to electrode array insertion, Intracochlear administration of dexamethasone for localized anti-inflammatory modulation prior to array insertion via the round window approach , 30, Experimental Group, Dexamethasone, Intracochlear administration of dexamethasone at 4 mg/mL , Single intraoperative administration prior to electrode array insertion, Intracochlear administration of dexamethasone for localized anti-inflammatory modulation prior to array insertion via the round window approach , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/06/2026 as requested by the editorial review team Control Group, Standard Saline Control, Standard surgical protocol utilizing standard saline irrigation, Single intraoperative administration prior to electrode array insertion, Standard surgical protocol utilizing standard saline irrigation prior to array insertion via the round window approach, 30, Active-Treatment of Control Group Control Group, Standard Saline, Standard surgical protocol utilizing standard saline irrigation, Single intraoperative administration prior to electrode array insertion, Standard surgical protocol utilizing standard saline irrigation prior to array insertion via the round window approach, 30, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 28/06/2026 as requested by the editorial review team TRUE, Institutional Review Board of Kafrelsheikh University Hospital, El-Geish Street, Kafrelsheikh University Campus, Kafrelsheikh, 33516 , Egypt, , 01 May 2026, +200473214998, KFS_MEU@med.kfs.edu.eg, 41524_38826_4737.pdf TRUE, Institutional Review Board of Kafrelsheikh University Hospital, El-Geish Street, Kafrelsheikh University Campus, Kafrelsheikh, 33516 , Egypt, , 01 May 2026, +200473214998, KFS_MEU@med.kfs.edu.eg, 41524_38826_4737.pdf