Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Rate of Adverse Events Through Discharge
研究概览
简要总结
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
详细描述
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months through 5 years of age
- •Candidates for ventilation tube placement
- •H-TTS used under moderate sedation and local anesthetic
排除标准
- 未提供
结局指标
主要结局
Rate of Adverse Events Through Discharge
时间窗: Through discharge, estimated to be approximately 90 minutes post-procedure
Rate of adverse events that occur between the end of the procedure and discharge
Percentage of Procedures Converted From Sedation to General Anesthesia
时间窗: Intra-operative
Percentage of procedures that require conversion from sedation to general anesthesia
Rate of Intra-operative Adverse Events
时间窗: Intra-operative
Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
次要结局
未报告次要终点