Tympanoseal (Tympanic Membrane Device) Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of Serious Adverse Events
研究概览
简要总结
The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.
详细描述
This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients over 2 years of age at enrollment
- •Documentation of a retained tympanostomy tube or persistent perforation less that 5 mm.
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study
排除标准
- •Active otorrhea or otitis media
- •History of cholesteatoma
- •Perforations on the edge of the tympanic membrane
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Subject is taking systemic corticosteroids
- •Subject requires continued use of any type of topical otic medication
结局指标
主要结局
Number of Serious Adverse Events
时间窗: 16 weeks
The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted. An SAE is defined as any adverse event occurring that results in any of the following outcomes: 1. Death 2. A life-threatening adverse experience 3. An inpatient hospitalization or prolongation of existing hospitalization 4. A persistent or significant disability/incapacity 5. A congenital anomaly/birth defect 6. Required Intervention to Prevent Permanent Impairment or Damage
次要结局
- Number of Participants With Treatment-related Adverse Events(16 weeks)