A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the VitalaTM Continence Control Device When Worn With SUR FIT Natura® Moldable TechnologyTM Skin Barrier Products Over a 12 Hour Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
研究概览
简要总结
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
详细描述
A Multi-Center, Open-Label, Feasibility Study to Assess the Safety and Performance of the Vitala (TM) Continence Control Device When Worn With SUR FIT Natura® Moldable Technology(TM) Skin Barrier Products Over a 12 Hour Period.
This is a non-randomized, open-label, multi-center clinical study to be conducted at approximately 5 investigative sites in the US that have expertise in the healthcare management of ostomates. Of the 25 subjects, this study targets a minimum of 15 current moldable users while the remaining users can be non-moldable users if moldable users can not be enrolled.
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
- •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.
- •Currently uses a SUR-FIT Natura® Moldable skin barrier or is willing to wear SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange sizes. Enrollment will target as many moldable product users as possible.
- •The investigator is relatively sure the subject will be able to wear a SUR-FIT Natura® Moldable Skin Barrier in 45mm or 57mm flange.
- •Is willing to remove and replace the skin barrier wafer after three days, or more often if desired.
- •Has a stoma that protrudes no more than 2 cm at rest (lying down on back).
- •Has demonstrated success in wearing a traditional pouching system. (Investigator judgment)
- •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 "L2" or greater according to the SACSTM Rating Scale.
- •Is receiving radiation in the area of the pouching system.
- •Is receiving chemotherapy other than a stable regimen of maintenance chemotherapy.
- •Requires convexity.
- •Requires a pouch belt while wearing Vitala™.
- •Has participated in a clinical study within the past 30 days.
结局指标
主要结局
Assessment of Safety measured by the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
时间窗: 28 Days
Safety will be assessed by measuring the frequency of adverse events (AEs) relating to the stoma (including GI, and surrounding skin events) and stoma and peristomal vascularity.
次要结局
- Performance (Restoration of Continence)(28 Days)
- Performance (Leakage Rates)(28 Days)
- Performance (Subjective Assessment)(28 Days)