Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
研究概览
简要总结
Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)
详细描述
Performance:
- Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
- Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont).
Human Factors and Usability:
- Ensure that representative intended users are able to operate the COBSS independently.
- Validate appropriate mitigations of use related hazards identified in risk management documentation.
- Uncover previously unforeseen use errors.
NOTES:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years of age
- •English speaking
- •Owns and uses a smartphone
- •Willing to sign the Informed Consent Form
排除标准
- •Pregnancy
结局指标
主要结局
Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
时间窗: 1 minute
CO concentrations in parts per million (ppm) in exhaled breath from subjects at a single visit will be assessed and reported in order to compare the CO measurements from COBSS to a control (predicate) device. The correlation will be reported as an R value. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. COBSS breath sample will take approximately 1 minute. Breath sample with the control device will take approximately 1 minute. The breath samples will be collected within 5-10 minutes of each other.
Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
时间窗: 1 minute for each question; up to 90 minutes for study session
User performance of participants in intended use scenarios will be assessed at a single visit. Participants will be observed if they can set up the device, use the device and interpret results. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. Outcome measure data table is tally of participants who were 'Successful' in each use scenario. For each participant, the single visit includes the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes. Observations are made throughout the study session. Assessments for individual tasks will take approximately 1 minute and assessments will be made over the study session which can last up to 90 minutes.
次要结局
- User Documentation Assessment With Questionnaire With Observer Ratings(Up to 90 minutes)
- Participant Assessment With Questionnaire Rating Scales(Up to 90 minutes)
- Number of Participants Answering "No" for the Subjective Feedback With Questionnaire(Up to 90 minutes)
研究者
David Utley, MD
President and CEO
Pivot Health Technologies Inc.