Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss
NCT ID: NCT06437054
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2025-09-15
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss
NCT04766853
Intracochlear Injection of Glucocorticoid
NCT07134075
Sudden Hearing Loss Multi-center Clinical Trial
NCT02026479
FX-322 in Adults With Age-Related Sensorineural Hearing Loss
NCT04601909
FX-322 in Adults With Severe Sensorineural Hearing Loss
NCT04629664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexamethasone+Saline+ICG
The experimental group received a single injection of Dexamethasone (5mg/ml) and Saline (D+Saline) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml).
Dexamethasone
Dexamethasone 5mg/ml
Indocyanine green(ICG)
ICG 25mg
Dexamethasone+Hyaluronic Acid+ICG
The experimental group received a single injection of Dexamethasone (5mg/ml) and Hyaluronic acid (D+HA) mixed in a 1:1 ratio (with a possibility of a second injection if necessary). Additionally, two drops of Indocyanine Green (ICG: 25mg) were added, approximately 100μl (2.5mg/ml).
Dexamethasone
Dexamethasone 5mg/ml
Hyaluronic acid
Hyaluronic Acid 20mg/2ml
Indocyanine green(ICG)
ICG 25mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone
Dexamethasone 5mg/ml
Hyaluronic acid
Hyaluronic Acid 20mg/2ml
Indocyanine green(ICG)
ICG 25mg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients whose original hearing ability has not been restored with existing standard treatment (oral, intravenous steroids)
* Those who have not participated in clinical trials within 3 months are selected as subjects
Exclusion Criteria
* When accompanied by lesion, infection, or anatomical deformity of the outer ear, middle ear, or inner ear
* Those with liver disease or metabolic disease or a history thereof
* History of hypersensitivity to indocyanine green or iodine hypersensitivity
* History of ear surgery
* Cases with posterior labyrinth lesions
* Patients with a history of hypersensitivity to the ingredients of this drug
* In addition, serious diseases such as end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive hemorrhage, and progressive cerebral hemorrhage are included Cases with brain disease and cancer are excluded from the study
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITV-2309-098-1469
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.