Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 8
- 主要终点
- Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
研究概览
简要总结
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
详细描述
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
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.
- •Subject is able and willing to comply with follow-up requirements.
- •Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
排除标准
- •Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
- •Significantly atrophic tympanic membrane.
- •Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
- •Anatomy precludes sufficient visualization and access to the tympanic membrane.
研究组 & 干预措施
Hummingbird TTS
Ear tube placement with the Hummingbird TTS
干预措施: Ear tube placement with the Hummingbird TTS (Device)
结局指标
主要结局
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
时间窗: intra operative
Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.
Number of Participants With Intra-operative Adverse Events
时间窗: Intra-operative
Any intra-operative adverse events, anticipated or unanticipated
次要结局
未报告次要终点