## Protocol Section
### Identification Module
**NCT ID:** NCT06437054

**Brief Title:** Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)

**Official Title:** Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)

#### Organization Study ID Info
**ID:** ITV-2309-098-1469
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2028-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-02-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-02-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Hearing Loss, Sensorineural

- Hearing Loss, Sudden

- Intratympanic Injection

**Keywords:**

- drug delivery

- Dexamethasone

- Hyaluronic acid

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Dexamethasone

- Other: Indocyanine green(ICG)

**Label:** Dexamethasone+Saline+ICG

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Dexamethasone

- Drug: Hyaluronic acid

- Other: Indocyanine green(ICG)

**Label:** Dexamethasone+Hyaluronic Acid+ICG

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexamethasone+Hyaluronic Acid+ICG

- Dexamethasone+Saline+ICG

**Description:** Dexamethasone 5mg/ml

**Name:** Dexamethasone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dexamethasone+Hyaluronic Acid+ICG

**Description:** Hyaluronic Acid 20mg/2ml

**Name:** Hyaluronic acid

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Dexamethasone+Hyaluronic Acid+ICG

- Dexamethasone+Saline+ICG

**Description:** ICG 25mg

**Name:** Indocyanine green(ICG)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Confirming healing time of perforation and inflammation

**Measure:** Verification of tympanic membrane with endoscopy (Safety)

**Time Frame:** 0, 1day and 1 week after intratympanic injection

**Description:** Checking a time duration of drug in middle and inner ear

**Measure:** Confirmation of inflammation and drug with CT imaging (Durability)

**Time Frame:** 0, 1day and 1 week after intratympanic injection

**Description:** Verifying therapeutic effect of intratympanic drug delivery vehicle

**Measure:** Valuation of hearing threshold with Pure tone audiometry (Efficacy)

**Time Frame:** 0, 1day, 1 week and/or 1 month after intratympanic injection

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with sudden hearing loss, Meniere's disease, ototoxic hearing loss, and noise-induced hearing loss of 25dB HL at the frequency at which hearing loss occurs as a result of pure tone hearing test
* 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:

* Pregnant or lactating women
* 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

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006311

- Term: Hearing Disorders

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000012678

- Term: Sensation Disorders

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M24420

- Name: Hearing Loss

- Relevance: HIGH

- As Found: Hearing Loss

- ID: M6840

- Name: Deafness

- Relevance: HIGH

- As Found: Hearing Loss

- ID: M9407

- Name: Hearing Loss, Sensorineural

- Relevance: HIGH

- As Found: Hearing Loss, Sensorineural

- ID: M6841

- Name: Hearing Loss, Sudden

- Relevance: HIGH

- As Found: Hearing Loss, Sudden

- ID: M9400

- Name: Hearing Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15490

- Name: Sensation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000034381

- Term: Hearing Loss

- ID: D000003638

- Term: Deafness

- ID: D000006319

- Term: Hearing Loss, Sensorineural

- ID: D000003639

- Term: Hearing Loss, Sudden

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000055675

- Term: Viscosupplements

- ID: D000020011

- Term: Protective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: HIGH

- As Found: Users

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M28295

- Name: Viscosupplements

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

- ID: D000006820

- Term: Hyaluronic Acid

### Misc Info Module

- Version Holder: 2024-05-31
