Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Successful Completion of Procedure In-office
研究概览
简要总结
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
详细描述
The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.
The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children.
Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo tympanostomy tube insertion in the clinic.
- •Children 6 months to 21 years old
- •Signed parental consent, and child assent documents as applicable.
- •Parent is fluent in English.
排除标准
- •Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
- •Anatomy precludes sufficient visualization and access to the tympanic membrane.
结局指标
主要结局
Percentage of Participants With Successful Completion of Procedure In-office
时间窗: Intra-procedure
Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up
时间窗: Follow-up between 3-10 weeks
AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS
时间窗: Intra-Procedure
Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.
次要结局
未报告次要终点