Multi-National Phase III Vitala™ 12-Hour Wear Test
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 12
- 主要终点
- Safety
研究概览
简要总结
The purpose of this clinical study is to demonstrate that the Vitala™ Continence Control Device is both safe and effective when worn up to 12 hours per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Is of legal consenting age.
- •Is able to read, write, and understand the study, the required procedures, and the study related documentation.
- •Has signed the informed consent.
- •Has an end colostomy of at least 12 weeks duration with formed or semi- formed effluent.
- •Is able to wear a Natura® skin barrier wafer flange in size 45mm or 57 mm.
- •Is willing to remove and replace the skin barrier wafer after three days, more often if desired.
- •Has a stoma that protrudes no more than 2 cm at rest.
- •Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
- •Is willing to participate in the trial for a total of 215 days. (approximately 7 months)
- •Is willing to meet with the investigator for a total of 12 scheduled visits plus additional visits as deemed necessary by the investigator.
- •Has the ability to do complete self-care.
排除标准
- •Has known skin sensitivity to any component of the products being tested.
- •Has a skin rating of "2" or greater according to the Skin Rating Scale.
- •Is receiving radiation in the area of the pouching system.
- •Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
- •Requires a pouch belt while wearing Vitala
- •Requires convexity or a moldable skin barrier.
- •Has participated in a clinical study within the past 90 days.
研究组 & 干预措施
Usual/Natura®/Vitala™
All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
干预措施: Usual (Device)
Usual/Natura®/Vitala™
All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
干预措施: Natura® (Device)
Usual/Natura®/Vitala™
All subjects will wear usual product for 21 days, followed by Natura® for 14 days and followed by Vitala™ for 159 days.
干预措施: Vitala™ (Device)
结局指标
主要结局
Safety
时间窗: 159 Days
Will be assessed by measuring the frequency of adverse events relating to the stoma (including gastrointestinal, stomal and surrounding skin events), microbiology profile and stomal vascularity.
Restoration of Continence
时间窗: 159 days
Absence of fecal leakage around the device.
次要结局
- Efficacy(215 Days)