A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome

This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome. CHARGE syndrome is frequently associated with complex temporal bone malformations, which may increase the risk of intraoperative complications and limit the applicability of standard surgical techniques.

The investigators reviewed preoperative imaging findings, operative records, and perioperative clinical data from pediatric patients with CHARGE syndrome who underwent cochlear implantation at Seoul National University Bundang Hospital. The objective of this study is to identify anatomical variations, characterize surgical difficulties, and describe practical surgical strategies that may enhance safety during cochlear implantation in this high-risk population.

The findings of this study are expected to contribute to improved understanding of cochlear and temporal bone anatomy in CHARGE syndrome and to support safer and more effective surgical planning for affected pediatric patients.

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Key information

Conditions

CHARGE Syndrome Abnormalities, Multiple Blindness Coloboma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deaf-Blind Disorders Deafness Ear Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam, Kyeonggido, 135-796, South Korea

About this study

This retrospective observational study evaluates surgical strategies and safety profiles of cochlear implantation in pediatric patients diagnosed with CHARGE syndrome. Medical records, preoperative imaging studies (CT and/or MRI), and operative reports were retrospectively reviewed to assess cochlear and temporal bone anatomy, surgical challenges, and intraoperative findings.

The study focuses on identifying anatomical variations commonly encountered in CHARGE syndrome and describing practical surgical approaches used to manage complex inner ear and temporal bone malformations. No interventions were assigned as part of this observational study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criteria

Pediatric patients diagnosed with CHARGE syndrome
Underwent cochlear implantation at Seoul National University Bundang hospital
Availability of preoperative imaging (CT and/or MRI)
Complete operative records available
Exclusion Criteria -Patients with CHARGE syndrome who did not undergo cochlear implantation

Treatment and study plan

No intervention (observational study)

Other

No intervention (Observation Study)

Primary outcomes

"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"

Time frame: Preoperative (Baseline)

This outcome evaluates the type and severity of cochlear, vestibular, and temporal bone malformations based on retrospective review of preoperative radiologic imaging, including computed tomography (CT) and magnetic resonance imaging (MRI), as documented in existing medical records.
"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"

Time frame: Preoperative (Baseline)

From existing medical records and preoperative imaging (CT/MRI)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

A Retrospective Observational Study Evaluating Surgical Strategies and Safety Profiles of Cochlear Implantation in Pediatric Patients With CHARGE Syndrome

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jan 6, 2026
Registry last updated: Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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