Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Procedure Success
研究概览
简要总结
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.
The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System
- •Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use
排除标准
- •Patients who are wards are not included
结局指标
主要结局
Procedure Success
时间窗: Day of procedure (day 0)
Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure
次要结局
- Tolerability (physician reported)(Day of procedure (day 0))
- Overall parent satisfaction(1 month post-procedure)
- Tolerability (parent reported) - anesthesia(Day of procedure (day 0))
- Recovery (physician reported)(Day of procedure (day 0))
- Recovery (parent reported)(Day of procedure (day 0))
- Anesthesia effectiveness - patients(Day of procedure (day 0))
- Parent satisfaction (informed)(1 month post-procedure)
- Anesthesia effectiveness - ears(Day of procedure (day 0))
- Tula Tympanostomy Tube retention(1 month post procedure)
- Tolerability (parent reported) - procedure(Day of procedure (day 0))
- Parent satisfaction (siblings)(1 month post-procedure)
- Parent satisfaction (recommendation)(1 month post-procedure)