A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Device Success
研究概览
简要总结
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
排除标准
- •Reaction to anesthesia
- •Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
- •Otitis externa
- •Active acute otitis media
- •Otitis media pathology requiring T-tubes
- •Stenosed ear canal
- •Anatomy that precludes visualization and access to tympanic membrane
- •Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
结局指标
主要结局
Device Success
时间窗: 0 days
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Safety of Tympanostomy Tube (TT) Delivery System
时间窗: 7 days
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
次要结局
- Proportion of Subjects With Procedure Success(0 days)
- Tube Retention(7 days)