A Phase 1 Clinical Trial to Assess the Performance and Safety of a Novel Ostomy Ring (OstoRing®) to Improve Ileostomy and Colostomy Management
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Pouching Equipment Wear Time/Lifespan
研究概览
简要总结
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
详细描述
In this crossover design trial, patients will be asked to first wear their normal ostomy pouching equipment for 28 days followed by 28 days with the OstoRing®. Patients may choose to continue using the OstoRing for an additional 19 days. Study visits will occur between each section of the trial and will involve a skin assessment and quality of life questionnaires. Additionally, over the course of the trial, participants will be asked to fill out a survey and take a picture of their stoma with ostomy pouching change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Are at least 18 years of age and have full legal capacity
- •Have had an end or loop ileostomy or colostomy for at least 6 months.
- •Have used a Hollister 2 piece New Image pouching system for at least 8 weeks
- •Able to provide informed consent
- •Have a stoma with a diameter of 57mm or less
- •Change their pouching system at least two times in seven days
排除标准
- •Unable to give informed consent.
- •Are pregnant or currently breastfeeding.
- •In the last 2 months has received or is currently receiving, chemotherapy or radiation therapy.
- •In the last month has received or is currently receiving systemic or local steroid treatment in the peristomal area.
- •Currently suffering from severe peristomal skin problems such as peristomal pyoderma, abscess.
- •Currently suffering from a peristomal hernia.
- •Known hypersensitivity toward any of the test product (OstoRing® is made of surgical grade stainless steel)
- •In the last 30 days has participated or is currently participating in a clinical study
- •Assessed with an ostomy skin tool score of ≥3
结局指标
主要结局
Pouching Equipment Wear Time/Lifespan
时间窗: 75 days
Mean pouching system wear time will be calculated with and without the OstoRing®.
Coloplast Tool Skin Assessment Score
时间窗: 75 days
The skin surrounding the peristomal area will be assessed at all study visits utilizing the coloplast skin score tool. Skin score may range from 0 to 15 with a smaller score indicating better skin condition in the peristomal area.
次要结局
- City of Hope Quality of Life Ostomy Questionnaire Score(75 days)