NCT00767390撤回不适用
CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.
研究概览
简要总结
The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Subject Informed Consent Form
- •Healthy subject
- •Age Range: 20 - 50 years
- •BMI - half o the subjects 18-25 and half >25
- •Chest cage normal anatomy and dimensions
- •No history of skin contact patch allergy, of any kind
排除标准
- •Chest cage bony deformity
- •Known skin allergies to patches, or dermatological conditions requiring therapy
- •Presence of any active skin lesion on chest or back
- •Any condition that preclude subject from lying down for six hours with minimal movement
- •Pregnancy
- •Subjects with devices, such as pace makers, IC, loop recorder
结局指标
主要结局
Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.
时间窗: 6 hours
次要结局
未报告次要终点
研究者
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