A Randomized Cross-over Trial Investigating Heylo, a Novel App Driven Digital Supporting Ostomy Product
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Emotional Impact Score (Scale From 0-100)
研究概览
简要总结
People with intestinal stomas can have, despite development of better ostomy products, problems with leakage which influence their quality of life negatively.
To overcome this, Coloplast has developed a new supporting ostomy product called Heylo™, which has an adhesive sensor layer that should be placed underneath the baseplate. The sensor layer consists of an electronic sensor system that continuously detects moisture and output leakage underneath the baseplate. A transmitter connected to the sensor layer continuously evaluates the incoming information and sends a status to a smartphone software application, which based on a predefined flow decides which information to deliver to the user about the baseplate status.
The overall aim of this clinical investigation is to evaluate the benefits of the new supporting product, Heylo compared to Standard of Care.
详细描述
The Investigational device - Heylo, is already CE-marked.
The investigation is an open-labelled, randomized cross-over trial with two test periods evaluating Heylo and Standard of Care.
In total 144 subjects having an ileostomy or an colostomy will be included and randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Has given written consent to participate by signing the Informed Consent Signature Form.
- •Is at least 18 years of age and has full legal capacity.
- •Has an ileostomy or colostomy with consistent liquid/mushy fecal output (5-7 Bristol scale*)
- •Is able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm).
- •Has experienced leakage** under the baseplate at least three times within the last fourteen days. **Leakage defined as output seeping under the baseplate"
- •Has worry about leakage to "some degree, high degree, or very high degree" (on a five-point Likert scale: Very low degree/Not at all, Low degree, some degree, High degree, very high degree)
- •Is willing to refrain from use of ostomy paste.
- •Has a smartphone compatible with the Heylo™ application
- •Is able to follow study procedures for 4 months (assessed by investigator or delegate)
排除标准
- •Is participating in other clinical investigations or has previously participated in this investigation
- •Is pregnant or breastfeeding
- •Has known hypersensitivity towards any of the products used in the investigation
- •Is using/ has a pacemaker
结局指标
主要结局
Emotional Impact Score (Scale From 0-100)
时间窗: 8 weeks
Measured by the validated OLI scale evaluated at the end of each test period. The questionnaire regarding Emotional impact contains 10 questions where the 4 answer options are: All of the time, Often, Sometimes and Rarely or never, which can be converted into a combined numerical score. The scale ranges from 0-100, where a score of 100 equals no impact and a score of 0 represents full impact.
次要结局
- Participation in Society Domain Score (Scale From 0-100)(8 weeks)