PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- PointCheck's Usability
研究概览
简要总结
This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia.
The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology.
The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision.
For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- •Male or Female aged 18 years or above.
- •Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.
- •Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
- •Able (in the Investigators opinion) and willing to comply with all study requirements
- •Exclusion Criteria
- •Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
- •Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
- •Participants with circulating tumour cells in previous or current lab determinations.
- •Participants with leukemia.
- •Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
- •Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
- •Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
排除标准
- 未提供
结局指标
主要结局
PointCheck's Usability
时间窗: Up to two-weeks
To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.
System Usability Scale (0-100 higher scores indicates better usability)
时间窗: Up to three-weeks
To confirm the usability of the system using the System Usability Scale
次要结局
- Number of participants with device-related adverse events as assessed by CTCAE v5.0(Up to three-weeks)
- PointCheck's Precision(Up to two-weeks)
- PointCheck's Accuracy(Up to three-weeks)
- PointCheck's Utility(Up to three-weeks)