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临床试验/NCT05198869
NCT05198869Unknown不适用

SpotLight-19 Research and Development Study

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 12,500 人开始时间: 2021年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
12,500
试验地点
2
主要终点
spectra indicative of COVID-19 infection

研究概览

简要总结

In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.

详细描述

Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19.

All individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate.

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
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Qualifies for COVID-19 testing as per Assessment Site protocol; or
  • •Is capable of cooperating with testing
  • •Is clinically stable such that the testing protocol may be completed safely

排除标准

  • •Extreme fingertip scarring or other physical condition that prevents use of the device

研究组 & 干预措施

Spectral scan (All participants)

Other
  1. Fitzpatrick skin assessment.
  2. Fingertip scanned using the SpotLight-19 device. The scan is approximately 10-20 seconds. Participants will not feel any sensation from the device, i.e., no heat, no pain, no cold, no vibration or pressure.
  3. Information collected from the medical record regarding participant age, COVID-19 vaccination status, presence of COVID-19 symptoms, and PCR test result.

干预措施: Spectral scan (Device)

结局指标

主要结局

spectra indicative of COVID-19 infection

时间窗: immediate upon scan

specific wavelengths of light that correlate with COVID-19 infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan Forster

Principal Investigator

Ottawa Hospital Research Institute

研究点 (2)

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