Tympanoseal (Tympanic Membrane Device) Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Number of participants with healed tympanic membrane perforations.
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 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patients over 2 years of age at enrollment
- •Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
- •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
- •Otorrhea or otitis media within 4 weeks prior to the operation
- •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/oral corticosteroids
- •Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal
研究组 & 干预措施
Tympanoseal
All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.
干预措施: Tympanoseal (Device)
结局指标
主要结局
Number of participants with healed tympanic membrane perforations.
时间窗: 12 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 the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator.
次要结局
- Number of participants with treatment-related adverse events(12 weeks)