Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
2021年6月17日 更新者：HTL-Strefa S.A.
A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.
研究概览
详细说明
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
研究类型
介入性
注册 (实际的)
20
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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Illinois
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Chicago、Illinois、美国、60606
- Chicago office
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Massachusetts
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Boston、Massachusetts、美国、02116
- Boston office
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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
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
- evaluators will be United States (US) residents
- evaluators can read, write, and speak English
- evaluators are at least 18 years old
- evaluators are able to understand and provide signed consent for the study
- evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
- evaluators have no concerns about the ability to perform the simulated skin pricking.
Exclusion Criteria:
- evaluators who do not routinely use safety lancets to collect capillary blood samples,
- evaluators who cannot read, write, and speak English,
- evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months
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：其他
- 分配：非随机化
- 介入模型：并行分配
- 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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其他：Simulation of skin pricking by using Medlance Plus
Estimation of the true failure rate of the device.
Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
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There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
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其他：Simulation of skin pricking by using myLance
Estimation of the true failure rate of the device.
Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries.
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There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
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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 |
|---|---|---|
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The true failure rate of the tested devices.
大体时间：At time of testing, up to 90 minutes
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At time of testing, up to 90 minutes
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Effectiveness of the safety lancet's sharps injury prevention features.
大体时间：At time of testing, up to 90 minutes
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Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement.
Numbers assigned to Likert scale express a "greater than" relationship.
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At time of testing, up to 90 minutes
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Evaluation of the safety of the devices based on the evaluators' assessments.
大体时间：At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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Evaluation of various aspects of the ease of use.
大体时间：At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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Detection of any handling, usability questions / issues associated with the device.
大体时间：At time of testing, up to 90 minutes ]
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At time of testing, up to 90 minutes ]
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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。
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 (实际的)
2019年9月24日
初级完成 (实际的)
2019年9月24日
研究完成 (实际的)
2019年9月27日
研究注册日期
首次提交
2021年6月9日
首先提交符合 QC 标准的
2021年6月17日
首次发布 (实际的)
2021年6月21日
研究记录更新
最后更新发布 (实际的)
2021年6月21日
上次提交的符合 QC 标准的更新
2021年6月17日
最后验证
2021年6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.
Safety lancet的临床试验
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University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University; University of Utah 和其他合作者招聘中
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Asklepios Kliniken Hamburg GmbHUniversity of Kiel完全的气道管理 | 喉罩气道 | 光纤插管