NCT06394115已完成不适用
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches: OUTFLOW Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Performance of Convatec ostomy pouches which have the novel coating
研究概览
简要总结
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Subjects with a colostomy or ileostomy
- •Age 18 years and over
- •Medically stable in the opinion of the investigator
- •Are able and willing to provide informed consent
- •Are able and willing to attend study visits
- •Currently use the same models of pouches as required by the study
- •Have a recent history of frequent pancaking (colostomy patients only)
- •Willing to stop using any lubricants in the pouches whilst participating in the study.
- •Subject has a valid email address for the Investigator to send links to study questionnaires and has access to a web enabled device.
排除标准
- •• Subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment
- •Subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period.
- •Allergic to any components of the Novel Lubricant inclusive of Soyabean and/or Vitamin E.
结局指标
主要结局
Performance of Convatec ostomy pouches which have the novel coating
时间窗: 16 days
To demonstrate the performance of Convatec ostomy pouches which have the novel coating
次要结局
- to investigate the safety of Convatec Ostomy Pouches modified with a novel coating(16 days)
研究者
研究点 (1)
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