NCT00939796已完成不适用
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Device Success
研究概览
简要总结
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- •Either male or female
排除标准
- •History of sensitivity or reaction to anesthesia chosen for the procedure
- •Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
- •Otitis externa
- •Active acute otitis media
- •Otitis media pathology
- •Stenosed ear canal
结局指标
主要结局
Device Success
时间窗: At procedure visit
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
次要结局
- Tube Retention(two weeks post-procedure)
- Cross-Over to Manual Myringotomy and Tube Placement(at procedure visit)
研究者
研究点 (4)
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