First Study: InterPoc's Safety and Tolerability in Adults With Second Study: Safety and Functionality of InterPoc
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
研究概览
简要总结
1 study: A pilot study of 8 adults with ileostomy was included in this trial of "first in human" with InterPoc™, an absorbent intestinal tampon safety and feasibility in humans with ileostomies.
Study 2: A study in total with 24 participants, evaluating both the safety but also the functionality of InterPoc in humans with ileostomies.
详细描述
Approximately 1 million individuals with ileostomies face limitations in design and complications with traditional stoma bags dating back to the 1950s. Colostomy care alternatives are unavailable for ileostomy patients, prompting the development of InterPoc™, an absorbent intestinal tampon.
The first study aims to assess its safety and feasibility in humans, while the second study focuses of the overall safety and functionality of the tampon in all 24 participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age of at least 18 Ileostoma at least created 6 months prior Ileostoma opening of at least 15 mm
排除标准
- •Inflamatory condition in the stoma or other intestine diagnosed within 2 months of the study Parastomal hernia daily output above 2 litters
结局指标
主要结局
Number of patients requiring pharmacological or surgical intervention due to the use of InterPOC for 6 hours
时间窗: 6 hours
Safety of Interpoc during use
次要结局
- Fecal output in stoma bag (ml) before and after the trail(6 hours)
- Pain during interpoc use(6 hours)
- Insertion and removal resistance(6 hour)
- InterPoc™ weight before and after insertion(6 hours)
- InterPoc™ Skin Irritation(6 hour)
- Early warning score during interpoc use (vital signs Pulse, blood pressure, oxygen saturation, respiratory rate, temperature),(6 hours)
- Scale (0-10) score of Discomfort, acid reflux, nausea(6 hours)
- Leakage around the stoma pouch(6 hours)
- Food consumption(6 hour)
研究者
Michael Patrick Achiam
DMSCI, associate professor
Rigshospitalet, Denmark