Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and functionality of the Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal incontinence.
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
- •Male and female patients, more than 18 years of age incontinent with liquid to semi-formed stool.
- •Non-ambulatory, hospitalized patients.
- •History of passage of at least 1 stool in 24 hours.
排除标准
- •Patients with suspected or confirmed rectal mucosal impairment or pathology.
- •Patients with have undergone descending colon or rectal surgery within the preceding six months.
- •Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local pathology (either benign and malignant) as observed during rectal examination.
- •Patients suspected to have impacted stool or is suffering from constipation.
- •Patients with confirmed pregnancy or suspected to be pregnant.
- •Patients that have planned MRI examination over the duration of the study.
- •Patients who have suffered recent cardiac arrest within the preceding 3 months.
- •Patients enrolled in another clinical study or clinical trial.
- •Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid , Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).
结局指标
主要结局
Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
时间窗: 120 +/- 8 hours
Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
Number of hours for which the device stays on without change or removal.
时间窗: 120 +/- 8 hours
Quantitative measure of duration of device use. The cause of the change or removal will be documented.
Visual confirmation that fecal material is diverted into the external collection bag through the device.
时间窗: 120 +/- 8 hours
Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
次要结局
- Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.(120 +/- 8 hours)