NCT06542367尚未招募不适用
Trans Canal Tympanoplasty With Local Anesthesia Using Fat Graft and "TachoSil"
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- closure of tympanic membrane perforation
研究概览
简要总结
Eligible participants with chronic tympanic membrane perforation (>6 month) will be given a detailed description and offered to participate in the study.
the study investigates the efficacy of trans canal tympanoplasty with local anesthesia using fat pad and "Tachosil". Participants will be followed for 1 year after the procedure with otological examination and successive hearing evaluations.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tympanic membrane perforation (>6 months).
- •Central tympanic membrane perforation.
- •Air bone gar of 35 dB or lower at the operated ear.
- •No active otorrhea in the operated ear in the preceding 3 month prior to the procedure.
- •No evidence of a retraction pocket and no suspicion for a cholesteatoma.
排除标准
- •Known ossicular chain dysfunction
- •The tympanic membrane perforation edges are not accessible/visualized transcanal
- •Pregnancy
- •Allergy to lidocaine
结局指标
主要结局
closure of tympanic membrane perforation
时间窗: 1 year following the procedure
the effectiveness of the tympanoplasty using far graft and "Tachosil" will be evaluated - whether close of tympanic membrane perforation occured.
次要结局
- Hearing results following tympanoplasty - Pure Tone Average(1 year following the procedure)
- Hearing results following tympanoplasty - Speech recognition threshold(1 year following the procedure)
- Hearing results following tympanoplasty - air bone gap.(1 year following the procedure)
研究者
Yoni Evgeni Gutkovich
Doctor
HaEmek Medical Center, Israel
相似试验
已完成
不适用
Tympanoseal (Tympanic Membrane Device) Clinical StudyTympanic Membrane PerforationNCT02918942Grace Medical, Inc.25
招募中
不适用
Tympanoseal Clinical StudyTympanic Membrane PerforationNCT05849844Grace Medical, Inc.45
Unknown
不适用
Cartilage Tympanoplasty for Recurrent Perforation Full Thickness Versus Partial Thickness GraftCartilage TympanoplastyNCT04815655Assiut University30
Unknown
不适用
Evaluation of Prognostic Factors in TympanoplastyTympanic Membrane PerforationNCT03416725Assiut University70
Unknown
不适用
Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to EndoscopyCholesteatomaChronic Otitis MediaNCT03294421Hospital de Clinicas de Porto Alegre64