Pediatric Adhesion and New Dermal Approach Study (PANDA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Performance Objective
研究概览
简要总结
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality. The Zio® monitor (Study Device) is an adhesive patch that is worn on the upper left chest for a specified period of time and is similar to a band aid. The Study Device contains a battery-powered heart monitor and will look at the heart rhythm and rate.
详细描述
This is a prospective single-arm study to demonstrate adequate analyzable time for use in pediatric patients up to 14 days of device wear. The study will incorporate a simplified skin preparation procedure. The objective is to evaluate analyzable time of the Zio® monitor device over the wear duration (up to 14 days) in a population 1 to 17 years of age. The study will incorporate a simplified skin preparation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is <18 years of age and ≥1 year of age and weighing ≥10 kg (22 pounds) at the time of device application.
- •Child's legally authorized representative is willing and able to provide informed consent and be able to assist the Child in completing all visits for the study. If the Child is old enough to provide assent, it will also be captured.
- •The prescribed Zio monitor wear time is planned to be up to 14 days.
排除标准
- •Child has a known allergy to adhesives or hydrogels or with family history of adhesive skin allergies.
- •Child has a visible skin injury or broken skin at location for study device placement.
- •Child has skin damage and a discharge of clear fluid or pus at the location for study device placement.
- •Child is unable or unwilling to participate or comply with study protocol.
- •The local Investigator deems the Child has a condition that could limit the Child's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. (It is understood that younger age groups of children may present development behavioral challenges in compliance with use of medical devices. Normal development stage should not be considered a reason for exclusion).
- •The child has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the child or when real-time or in-patient monitoring should be prescribed.
- •Child has an external or wearable cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
- •Child has a neuro-stimulator, as it may disrupt the quality of ECG data.
研究组 & 干预措施
Single-arm study to analyzable time for use in pediatric patients up to 14 days
Zio monitor
干预措施: Zio monitor (Device)
结局指标
主要结局
Performance Objective
时间窗: Up to 14 days
The duration of non-artifact ECG signal as a proportion of the device total wear time will be assessed. The sample proportion with analyzable time \>80% is assumed to be 90%. The performance objective will be met if the lower bound of the 95% confidence interval is at least 75%. Percent analyzable time is defined as the duration of non-artifact ECG signal as a proportion of the device total wear time.
次要结局
未报告次要终点