Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
2015年9月17日 更新者：G.R. Dome Medical Ltd.
The study will evaluate device performance and user satisfaction in the UriCap-RM, an FDA cleared non-invasive urine collection device for men.
研究概览
详细说明
Following various disease conditions such as trauma, orthopedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. Others may be incontinent of urine. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated; in many cases a catheter is placed despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used, or a condom-type urine collection device. These may be associated with skin irritation and infection.
The study will evaluate the UriCap-RM non-invasive urine collection device in hospitalized men.
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Male ≥ 18 years old.
- Empties the bladder completely on voiding
- A clinical indication for an indwelling catheter, use of pads or diapers
- Subject has signed an informed consent form, is cooperative and willing to complete all study procedures
- Absence of localized disease at the site of device application - no discharge, itching, inflammation or skin condition - - on visual examination
- Subject has no hypersensitivity to silicon.
Exclusion Criteria:
- Known allergy to silicon
- Dysuria
- Urinary retention - Post-void residual urine more than 300cc
- Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
- Diagnosed with acute renal failure, according to investigator judgement.
- Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the subject's well-being or successful participation in the study
- Participating in another clinical study.
- Financial interest in the Sponsor Company or a competitor company by subject or a family member
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：UriCap-RM
The device is comprised of a reusable part and a single use adhesive tape.
The device is removed once daily and the reusable part is rinsed, dried and reapplied with a new adhesive tape.
|
UriCap-RM is comprised of a reusable part and a single use adhesive tape.
The reusable part is applied over the urethral meatus and is held in position by a stabilizer and adhesive tape.
It is connected to a standard urine collection bag.
The UriCap-RM is used on male patients who would otherwise use diapers, a condom-type urine collection device or an indwelling catheter for urine collection.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Performance of the device in collecting urine
大体时间：1-30 days
|
Multiple variables will be assessed and their measurements aggregated to arrive at number of events reported:
|
1-30 days
|
|
Patient Comfort
大体时间：1-30 days
|
Daily assessment of comfort rated in the "Universal Pain Assessment Scale" of 1-10.
|
1-30 days
|
|
Healthcare provider (HCP) satisfaction in device use
大体时间：up to 60 days
|
Nurses will fill a "Treatment Satisfaction Questionnaire" once after termination of all study patients
|
up to 60 days
|
|
Patient Satisfaction in Device Use
大体时间：1-30 days
|
Administration of a "Treatment Satisfaction Questionnaire" at termination of device use.
|
1-30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness of defined device cleaning procedure
大体时间：1-30 days
|
The reusable part will be visually inspected after cleaning for suitability for reuse.
Devices which exhibit any of the following properties will be discarded: color change, residual soiling, loss of mechanical integrity, torn, rough edges.
The effectiveness of the cleaning procedure will be measured as the average number of days the device can be reused.
|
1-30 days
|
|
Number of leakage events resulting from device movement
大体时间：1-30 days
|
1-30 days
|
|
|
Number of patients with Adverse Events that are related to device use
大体时间：1-30 days
|
1-30 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elad Schiff, MD、no affiliation
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (预期的)
2015年10月1日
研究完成 (预期的)
2015年10月1日
研究注册日期
首次提交
2015年8月16日
首先提交符合 QC 标准的
2015年8月19日
首次发布 (估计)
2015年8月20日
研究记录更新
最后更新发布 (估计)
2015年9月18日
上次提交的符合 QC 标准的更新
2015年9月17日
最后验证
2015年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
UriCap-RM的临床试验
-
Region Örebro CountyÖrebro kommun; Kumla kommun撤销
-
University Hospital, Clermont-Ferrand完全的
-
Rhythm Pharmaceuticals, Inc.主动，不招人