Multicenter Pilot Study to Describe the Performance of a New Device in Patients With Colostomy
2017年2月3日 更新者：BBraun Medical SAS
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
研究概览
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Dijon、法国、21000
- Centre Georges François Leclerc
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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
全部
描述
Inclusion Criteria:
- Patient is at least 18 years old
- Patient having a colostomy with a diameter less than 30 mm for users of Ø 55 mm pouches or having a colostomy with a diameter less than 40 mm for users of Ø 65 mm pouches
- Patient having a colostomy for at least 1 month
- Patient using currently the two-piece flat ostomy appliance Flexima®/Softima® 3S for at least 2 weeks and being satisfied
- Patient having a stoma protusion smaller than or equal to 1.5 cm
- Patient capable to apply and remove the appliance himself or with the help of a caregiver (except health care professional)
- Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
- Patient agreeing to test the new appliance during the training phase (5±3 days) and during the study device usage phase (14±3 days)
- Patient covered by social security
Exclusion Criteria:
- Patient experiencing repeated leakages with the usual pouching system
- Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
- Patient receiving or having received, within the last month, chemotherapy, radiotherapy or corticotherapy
- Patient already participating in another clinical study or who have previously participated in this investigation
- Pregnant or breast-feeding woman
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 |
|---|---|
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实验性的：AOS-C2000-B
A new 2-piece appliance composed with 2 parts : a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
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1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
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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 |
|---|---|---|
|
Description of efficacy in term of type of bag deployment and leakage prevention
大体时间：At least 1 time per day during 14±3 days
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After each change of the investigational product, the patient will describe on a 3-point scale the type of deployment "manual", "spontaneous - in link with stools or gas", "spontaneous - no link with stools or gas"
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At least 1 time per day during 14±3 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peristomal skin evaluation with DET score scale
大体时间：baseline and 5±3 days and 14±3 days
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baseline and 5±3 days and 14±3 days
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Investigational product bag deployment reason
大体时间：At each bag change during 14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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At each bag change during 14±3 days
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Ease of bag deployment
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of special bag handling
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational product bag ease of use of gas release button
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of control of gas release button
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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General impression about the investigational device before use
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device wearing comfort
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device flexibility
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device discretion
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Ease of base plate handling
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
|
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Investigational device adhesivity during wear time
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device filter performance with deployed bag
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Investigational device filter performance with undeployed bag
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Efficacy of Investigational device gas release button
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Noise during Investigational device wear time
大体时间：14±3 days
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Evaluation with a questionnaire (4-points very satisfying to not at all satisfying)
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14±3 days
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Overall satisfaction questionnaire of the collection volume of the bag of the Investigational device
大体时间：14±3 days
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14±3 days
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Overall security feeling questionnaire with the Investigational device
大体时间：14±3 days
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14±3 days
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Overall satisfaction questionnaire with the Investigational device
大体时间：14±3 days
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14±3 days
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Overall satisfaction questionnaire regarding bag deployment of the Investigational device
大体时间：14±3 days
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14±3 days
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Overall satisfaction questionnaire with cap cover of the Investigational device
大体时间：14±3 days
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14±3 days
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General impression about body image during use of the investigational product
大体时间：14±3 days
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(4-points very satisfying to not at all satisfying)
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14±3 days
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Assessment questionnaire of willingness to use and the frequency of use in the future
大体时间：14±3 days
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14±3 days
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Assessment of the investigational device wear time
大体时间：14±3 days
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14±3 days
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Assessment questionnaire preference between the investigational device and usual appliance
大体时间：14±3 days
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14±3 days
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Assessment of use of accessories
大体时间：At each bag change during 14±3 days
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Choice between some accessories
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At each bag change during 14±3 days
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Assessment of the quality of life with Stoma-QoL questionnaire
大体时间：At baseline, at 5±3 days and 14±3 days
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At baseline, at 5±3 days and 14±3 days
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Number of participants with Adverse Event as a measure of safety and tolerability
大体时间：At baseline, at 5±3 days and 14±3 days
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At baseline, at 5±3 days and 14±3 days
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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：Mahaut LECONTE, MD、University Hospital of Paris - Cochin
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11月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2015年11月4日
首先提交符合 QC 标准的
2015年11月10日
首次发布 (估计)
2015年11月11日
研究记录更新
最后更新发布 (估计)
2017年2月6日
上次提交的符合 QC 标准的更新
2017年2月3日
最后验证
2017年2月1日
更多信息
与本研究相关的术语
其他研究编号
- OPM-G-H-1401
- 2015-A00611-48 (其他标识符：FRENCH HEALTH AUTORITY)
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.