NCT00556972终止不适用
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
研究概览
简要总结
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness.
详细描述
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System. The investigator will complete a questionnaire for each of the tested products and the products will be evaluated as regards leakage, wear time, and skin-friendliness
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is at least 18 years of age
- •The subject has fecal incontinence
排除标准
- •The subject is pregnant and/or breastfeeding
- •The subject has perianal fistulas and/or hemorrhoids
- •It's estimated that the subject's perianal skin makes it inappropriate for subject to participate in the study (i.e. in case of damaged skin, very sweaty skin or very sinuous and folded skin)
结局指标
主要结局
The Primary Outcome Measure is Device Wear Time (Time From the Device is Applied Until it is Removed)
时间窗: 5 days
次要结局
- Is the Barrier Size and Shape Satisfactory(Subjects were followed for the duration of the study, an average of 23 hours)
- What is Your Assessment of the Ease of Correct Application of the Anal Adhesive?(After application of product)
- Assessment of Skin 0-2 Inches From the Edge of the Anus(Subjects were evaluated before and after test)
研究者
研究点 (2)
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