Verification of the Efficacy/Safety of the Mixed Drug Injectable Delivery Vehicle for Treating Intractable Hearing Loss (Pilot Study)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 26
- 主要终点
- Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Hyaluronic acid (Drug)
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).
干预措施: Dexamethasone (Drug)
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).
干预措施: Indocyanine green(ICG) (Other)
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).
干预措施: Dexamethasone (Drug)
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).
干预措施: Indocyanine green(ICG) (Other)
结局指标
主要结局
Comparison of Auditory Threshold Values Between Two Groups to Confirm Treatment Efficacy in 26 participants
时间窗: 0, 1day, 1 week and/or 1 month after intratympanic injection
Verifying therapeutic effect of intratympanic drug delivery vehicle (Efficacy)
Analysis of Side Effect Rate through tympanic membrane endoscopy Imaging in 26 participants
时间窗: 0, 1day and 1 week after intratympanic injection
Confirming healing time of perforation and inflammation (Safety)
Analysis of Drug Duration through CT Imaging in 26 participants
时间窗: 0, 1day and 1 week after intratympanic injection
Checking a time duration of drug in middle and inner ear (Durability)
次要结局
未报告次要终点