Pivot Breath Sensor Performance Study
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
- User Performance of Pivot Breath Sensor
研究概览
简要总结
A clinical study enrolling 70 subjects to:
- evaluate the user performance of the Pivot Breath Sensor
- compare measurements from the Pivot Breath Sensor to a similar device
- assess user documentation comprehension
- obtain feedback on the Pivot Breath Sensor via rating scales. No medical decisions will be made related to test results.
详细描述
The objectives of this performance study are to:
- Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
- We will assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Inc.) and a similar device.
- assess user documentation comprehension
- obtain feedback on the Pivot Breath Sensor via rating scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Owns and uses a smartphone
- •Willing to sign the Informed Consent Form
- •Resident of the United States
- •Able to read and comprehend English
排除标准
- •Prior experience with a study sponsored by Carrot Inc.
- •Pregnancy
结局指标
主要结局
User Performance of Pivot Breath Sensor
时间窗: Each study session lasted up to 60 minutes per participant. Use performance was assessed at approximately 10-15 minutes into the study session.
Assess user performance of the study device at a single visit. Participants will be observed if they can set up the Pivot Breath Sensor, and whether they can use the device. Observer ratings include 'Successful' and 'Unsuccessful'. Specific attention will be given to assess if any harms can occur from observed use errors. "Successful" = the participant was able to complete the task independently, safely, effectively, and without difficulty. "Unsuccessful" = the participant was unable to complete the task independently, safely, effectively, and/or without difficulty. Includes instances where the participant required study moderator assistance.
Compare Performance of Pivot Breath Sensor With a Similar Device.
时间窗: Each study session lasted up to 60 minutes per participant.
Compare study device performance with a similar device at a single visit. Participants will then be asked to use a similar CO breath sensor device. The correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the similar breath sensor will be assessed.
次要结局
- Participant Feedback Using Rating Scale(Each study session lasted up to 60 minutes per participant. Use performance was assessed with rating scales at approximately 35 minutes into the study session.)
- User Documentation Assessment With Observer Ratings(Each study session lasted up to 60 minutes per participant. The user documentation assessment with observer ratings was done between approximately 10 and 35 minutes into the study session.)
研究者
Jennifer Marler, MD
Senior Director, Clinical and Medical Affairs
Pivot Health Technologies Inc.