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
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural 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 (TTDS) in the placement of tympanostomy tubes (TTs) 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
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 1 year of age
- •Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
- •Either male or female -
排除标准
- •History of sensitivity or reaction to anaesthesia
- •Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
- •Otitis externa
- •Active acute otitis media
- •Thickened Tympanic Membrane
- •Thick mucoid effusion (also known as "glue ear")
- •Otitis media pathology requiring T-tubes -
研究组 & 干预措施
Tympanostomy Tube placement
Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
干预措施: Tympanostomy Tube Delivery System (Device)
结局指标
主要结局
Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.
时间窗: Procedural
TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.
次要结局
- Percentage of Ears With Adverse Events(12 months post procedure)
- Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure(12 months)
- Percentage of Patent Tubes(9 Months)
- Percentage of Patent Tubes(30 days)
- Percentage of Patent Tubes(3 months)
- Percentage of Patent Tubes(6 months)
- Percentage of Ears With Adverse Events(30 days)
- Percentage of Ears With Adverse Events(3 months)
- Percentage of Ears With Adverse Events(6 months)
- Percentage of Ears With Adverse Events(9 months)