SpotLight-19 Research & Development Study

January 17, 2022 updated by: Alan Forster, Ottawa Hospital Research Institute

SpotLight-19 Research and Development Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

12500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1S 5T1
        • Not yet recruiting
        • COVID-19 CHEO Assessment Centre
        • Contact:
          • Nadine Drosdowech
        • Principal Investigator:
          • Ken Farion, Dr.
      • Ottawa, Ontario, Canada, K1S5T1
        • Recruiting
        • COVID-19 Assessment Centre for Adults
        • Contact:
          • Cassie Matthews
        • Principal Investigator:
          • Alan Forster, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Spectral scan (All participants)
  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.
Device: Spectral scan
Consenting participants will have a SpotLight-19 scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spectra indicative of COVID-19 infection
Time Frame: immediate upon scan
specific wavelengths of light that correlate with COVID-19 infection
immediate upon scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

ISBRG Corp

Investigators

  • Principal Investigator: Rae Lake, MD, ISBRG Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20210902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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