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This study was withdrawn before enrollment due to challenges in participant recruitment. A revised study protocol will be initiated under a new research project.
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This study is a prospective, randomized pilot study. To verify an efficacy/safety of the mixed drug injectable delivery vehicle for treating intractable hearing loss. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
The goal of this clinical trial (pilot study) is to evaluate the Efficacy and Safety of Combined Hyaluronic Acid and Dexamethasone Treatment in Patients with Hearing Loss. The main questions it aims to answer are: • Q1. Verification of safety, • Q2. Therapeutic effect of drug injection on sensorineural hearing loss. Participants will undergo several assessment tests (Verification of adverse effects in the external and middle ear through endoscopy, Confirmation of adverse effects through imaging, Hearing test to check for additional hearing loss, Check if subjective ear fullness persists for more than a week aside from the drug effect). If there is a comparison group: Researchers will compare dexamethasone and hyaluronic acid to verify hearing improvement and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone+Saline+ICG | Active Comparator | 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). |
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| Dexamethasone+Hyaluronic Acid+ICG | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 5mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants | Confirming healing time of perforation and inflammation (Safety) | 0, 1day and 1 week after intratympanic injection |
| Analysis of Drug Duration through CT Imaging in 26 participants | Checking a time duration of drug in middle and inner ear (Durability) | 0, 1day and 1 week after intratympanic injection |
| Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants | Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy) | 0, 1day, 1 week and/or 1 month after intratympanic injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Hyaluronic acid | Drug | Hyaluronic Acid 20mg/2ml |
|
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| Indocyanine green(ICG) | Other | ICG 25mg |
|
|
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D003639 | Hearing Loss, Sudden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D006820 | Hyaluronic Acid |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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