Verification of the Efficacy / Safety of the Intratympanic Drug Delivery Vehicle for Treating Intractable Hearing Loss (pilot Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Verification of tympanic membrane with endoscopy (Safety)
研究概览
简要总结
This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.
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
- •Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
- •Patients whose hearing has not been restored after standard treatment
- •Patients do not participate in clinical trials within 6 months
排除标准
- •Patients with retrocochlear lesion
- •Patients with history of hypersensitivity to the ingredients of this drug
- •Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.
研究组 & 干预措施
Dexamethasone+Saline
干预措施: Dexamethasone (Drug)
Dexamethasone+Hyaluronic Acid
干预措施: Dexamethasone (Drug)
Dexamethasone+Hyaluronic Acid
干预措施: Hyaluronic acid (Drug)
结局指标
主要结局
Verification of tympanic membrane with endoscopy (Safety)
时间窗: 3-4 weeks after intratympanic injection
Confirming healing time of perforation and inflammation
Confirmation of inflammation and drug with CT imaging (Durability)
时间窗: 1 day and/or 1 weeks after intratympanic injection
Checking a time duration of drug in middle and inner ear
Valuation of hearing threshold with Pure tone audiometry (Efficacy)
时间窗: 3-4 weeks after intratympanic injection
Verifying therapeutic effect of intratympanic drug delivery vehicle
次要结局
未报告次要终点