A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With In-office Tube Placement Procedure Success
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
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
- •Scheduled to undergo tympanostomy tube insertion
- •At least 6 months old
- •Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
排除标准
- •History of sensitivity or reaction to anesthesia chosen for the procedure
- •Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- •Otitis externa
- •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
Percentage of Subjects With In-office Tube Placement Procedure Success
时间窗: Day 0
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Percentage of Tubes Successfully Placed Using a TTDS Device
时间窗: Day 0
Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only. A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
次要结局
- Number of Retained (TTDS-placed) Tubes(14 days)