CHARGE SyndromeNCT07320482
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
An observational study of CHARGE Syndrome, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CHARGE Syndrome
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2025to 22 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of pediatric patients diagnosed with CHARGE syndrome who underwent cochlear implantation at Seoul National University Bundang Hospital. These patients typically present with complex inner ear and temporal bone malformations, including cochlear hypoplasia, semicircular canal anomalies, and aberrant facial nerve courses. All participants included in this retrospective review had available preoperative imaging (CT and/or MRI) and complete operative records.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Kyeonggido, 135-796
About this study
Official title: A Retrospective Observational Study Evaluating Surgical Strategies and Safety Profiles of Cochlear Implantation in Pediatric 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.
Read the detailed description
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.
- Conditions
- CHARGE Syndrome
- Being tested
- No intervention (observational study)
- Medical subject headings
- CHARGE Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (Observation Study)
What is being measured
The primary outcome is the main question the study is designed to answer.
"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"
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.
Measured: Preoperative (Baseline)
"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome"
From existing medical records and preoperative imaging (CT/MRI)
Measured: Preoperative (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start21 Nov 2025
- Primary completion22 Nov 2025
- Study completion22 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHARGE SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Choi Byung Yoon, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320482
- Sponsor's protocol ID
- B-2512-1012-104
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study involves a small cohort of pediatric patients with CHARGE syndrome, a rare condition in which the risk of re-identification is high even after de-identification. The dataset includes sensitive clinical details, imaging findings, and operative records that cannot be safely disclosed under institutional privacy and ethical policies
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study Evaluating Surgical Strategies and Safety Profiles of Cochlear Implantation in Pediatric Patients With CHARGE Syndrome
- ClinicalTrials.gov ID
- NCT07320482
- Acronym / sponsor ID
- B-2512-1012-104
- Conditions
- CHARGE Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- 22 Nov 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of pediatric patients diagnosed with CHARGE syndrome who underwent cochlear implantation at Seoul National University Bundang Hospital. These patients typically present with complex inner ear and temporal bone malformations, including cochlear hypoplasia, semicircular canal anomalies, and aberrant facial nerve courses. All participants included in this retrospective review had available preoperative imaging (CT and/or MRI) and complete operative records.
Key inclusion criteria (5 listed)
- Exclusion Criteria -Patients with CHARGE syndrome who did not undergo cochlear implantation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention (Observation Study) | Other | – |
Primary outcome
"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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study involves a small cohort of pediatric patients with CHARGE syndrome, a rare condition in which the risk of re-identification is high even after de-identification. The dataset includes sensitive clinical details, imaging findings, and operative records that cannot be safely disclosed under institutional privacy and ethical policies
Related trials for CHARGE Syndrome
RecruitingObservational study
Characterization and Contribution of Genome-wide DNA Methylation (DNA Methylation Episignatures) in Rare Diseases With Prenatal Onset
Rare Fetal Genetic Diseases, Congenital Malformation
Enrolling by invitation
Palliative Care Needs of Children With Rare Diseases and Their Families
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
RecruitingObservational study
GROWing Up With Rare GENEtic Syndromes
Prader-Willi Syndrome, PWS-like Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHARGE Syndrome, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Characterization of Cochlear and Temporal Bone Anatomical Abnormalities in Pediatric Patients With CHARGE Syndrome" (time frame: Preoperative (Baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.