NCT02150044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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Ear Outcome Success
研究概览
简要总结
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
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
- •Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
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 requiring T-tubes
- •Stenosed ear canal
- •Anatomy that precludes sufficient visualization of and access to the tympanic membrane
- •Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
结局指标
主要结局
Ear Outcome Success
时间窗: Day 0 (at procedure visit)
Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
次要结局
- Procedure Success(Day 0 (at procedure visit))
- Tube Retention(1 week)
研究者
研究点 (1)
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