A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Leakage & Wear Time
研究概览
简要总结
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
详细描述
The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has an ostomy
- •Is at least 18 years of age
- •Has a stoma for at least 3 months
- •Other than thier ostomy is considered to have a healthy/stable health
- •Is able to take care of their stoma
排除标准
- •Known sensitivity to any of the ostomy devices or components
- •Is undergoing chemotherapy or radiotherapy
- •Has participated in a clinical study within the past 30 days
- •Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion
研究组 & 干预措施
Ostomy 1
3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
干预措施: Ostomy accessory (Device)
Ostomy 2
3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1
干预措施: Ostomy accessory (Device)
Ostomy 3
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product
干预措施: Ostomy accessory (Device)
Ostomy 4
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product
干预措施: Ostomy accessory (Device)
Ostomy 5
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2
干预措施: Ostomy accessory (Device)
Ostomy 6
3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1
干预措施: Ostomy accessory (Device)
结局指标
主要结局
Leakage & Wear Time
时间窗: 10 days
Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.
次要结局
- Number of adverse events(10 days)