Evaluation of the Goldcrest Patch Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Collection of Skin Integrity Quality
研究概览
简要总结
The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
详细描述
The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Skin irregularities or other characteristic (such as scars, moles) on abdominal area that could interfere with completion of study procedures or identify a subject;
- •Subjects who have implantable devices such as Transcutaneous Electrical Nerve Stimulation (TENS) machines, Cardiac Pacemakers or Cardiac Defibrillators
- •Subjects expected to be at risk from participation for any reason, such as those with known allergy or sensitivity to adhesive materials that may be used in the study, such as silicone;
- •Subjects over the age of 70;
- •Unable to read or speak English language
- •Direct employees or contractors of GE HealthCare, or any company that makes fetal monitoring devices.
- •Exclusion criteria that apply to specific arms only:
- •Non-Pregnant Arm: Subjects who are currently pregnant, or unsure of pregnancy status per self-report;
- •Pregnant Arm: Multiple gestation pregnancy or those self-reported to have been diagnosed as high risk by a provider (e.g., pre-eclampsia, gestational hypertension, being followed by a perinatologist).
结局指标
主要结局
Collection of Skin Integrity Quality
时间窗: 18 hours
To collect of skin integrity quality from a skin assessment scale the from the patch's after 18-hours of wear.
次要结局
- Collection of ECG Electrical Signal Data(18 hours)
- Collection of Subject Activity(18 hours)
- Collection of Patch Electrical Signal Data(18 Hours)