A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Subjects With Procedural, Serious and Device-related Adverse Events.
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 (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis 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)
- •No history of sensitivity or reaction to anesthesia chosen for the procedure
排除标准
- •Pregnant or lactating females
- •Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- •Otitis externa
- •Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
- •Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- •Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- •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
研究组 & 干预措施
Tympanostomy Tube Placement
干预措施: Tympanostomy tube placement (Acclarent iontophoresis device) (Device)
结局指标
主要结局
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
时间窗: Procedure through 2 weeks post-procedure
Adverse events which are procedural, serious, and device-related.
Device Success
时间窗: Day 0 (day of procedure)
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
次要结局
- Procedure Success(Day 0 (day of procedure))
- Procedure Tolerability(Day 0 (day of procedure))
- Tube Retention(2 weeks post-procedure)