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Mitigating Insertion Trauma in the Fibrotic Cochlea

A Randomized Trial Comparing Viscoelastic, Anti-Inflammatory, and Standard Approaches Across Multiple Electrode Arrays

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202607898373634
Enrollment
90
Registered
2026-07-06
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear, Nose and Throat

Interventions

Hyaluronic Acid
Dexamethasone

Sponsors

Kafrelsheikh University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Optimal Insertion Force (Tactile and mechanical resistance encountered during electrode array advancement) ;Insertion Trials (Precise number of manual manipulations or retractions required to achieve full array insertion)

Secondary

MeasureTime frame
Electrophysiological Metrics (Baseline impedance values across active electrode channels);Scalar preservation and final anatomical array position verified via transorbital X-rays

Countries

Egypt

Contacts

Public ContactMohamed AbdelMaboud

Faculty of Medicine Al Azhar University

MohamedAbdel-Maboud.6.206@azhar.edu.eg+201028324400

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026