NCT02550314已完成3 期
A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan0 个研究点目标入组 20 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Closure of tympanic membrane perforation in the observation period at16 wks
研究概览
简要总结
To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed concent obtained
- •At the time of obtaining informed consent, Ages ranged from over 20 to 80
- •At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded)
排除标准
- •TMP caused by burn or radiation therapy
- •In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry
- •Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity
- •No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge
- •History of tympanoplasty
- •A Part of the eardrum adhered to tympanic cavity
- •By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration)
- •Abnormality in the chain and ear ossicles
- •Air-bone gap difference more than 25dB by patch hearing test
- •Unable to see whole edge of TMP due to narrow external auditory canal
- •Unable to wash out Ear drops during the treatment period
- •Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more)
- •Presenting with autoimmune disease
- •History of malignancy within 3 years prior to obtained informed concent
- •Administration of immunosuppressive agent or anti-cancer-agent
- •History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others
- •Though out the period from screening to treatment, patient who is unable to wash out "Thrombolytic agent", "Anticoagulant", "Anti-platelet agent", "Procoagulant agent", "anti-line solvent"and"aprotinin formulation"
研究组 & 干预措施
NPC-18,FBG-18
Experimental
Intervention drug:
NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue
Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane
干预措施: fiblast,gelatin sponge,fibrin glue (Drug)
结局指标
主要结局
Closure of tympanic membrane perforation in the observation period at16 wks
时间窗: Closure of tympanic membrane perforation in the observation period at16 wks
次要结局
- Improvement of hearing level in the observation period at 4 wks and 16 wks(Improvement of hearing level in the observation period at 4 wks and 16 wks)
- Closure of tympanic membrane perforation in the observation period at 4 wks(Closure of tympanic membrane perforation in the observation period at 4 wks)
- Air-bone gap in the observation period at 4 wks and 16 wks(Air-bone gap in the observation period at 4 wks and 16 wks)
- The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks(The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks)
- Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks(Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks)
研究者
Shin-ichi Kanemaru
director
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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