Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The true failure rate of the tested devices
研究概览
简要总结
A simulated clinical use testing on the HTL-Strefa's safety lancets
详细描述
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.
The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
- •(HCP evaluators only) - 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.
- •Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.
排除标准
- •They do not routinely use safety lancets to collect capillary blood samples,
- •They cannot read, write, and speak English,
- •They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- •They have participated in a product evaluation or marketing study involving safety lancets within the last six months
- •Lay people:
- •They cannot read, write, and speak English,
- •They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- •They have participated in a product evaluation or marketing study involving safety lancets within the last six months
研究组 & 干预措施
simulation of skin pricking type 450
The evaluator simulated the capillary blood sampling with the safety lancet type 450
干预措施: ergoLance safety lancet (Device)
simulation of skin pricking type 610
The evaluator simulated the capillary blood sampling with the safety lancet type 610
干预措施: Acti-Lance safety lancet (Device)
结局指标
主要结局
The true failure rate of the tested devices
时间窗: At time of testing, up to 90 minutes
Effectiveness of the safety lancet's sharps injury prevention features
时间窗: At time of testing, up to 90 minutes
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.
次要结局
- Subjective assessments regarding evaluators' interactions with the tested safety lancets(At time of testing, up to 90 minutes)
- Safety of the devices based on the evaluators' assessments (five-point response scale)(At time of testing, up to 90 minutes)
- Various aspects of the ease of use.(At time of testing, up to 90 minutes)
- Any handling, usability questions / issues associated with the device(At time of testing, up to 90 minutes)