SpotLight-19 Research & Development Study

NCT ID: NCT05198869

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Spectral scan

Intervention Type DEVICE

Consenting participants will have a SpotLight-19 scan

Interventions

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Spectral scan

Consenting participants will have a SpotLight-19 scan

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ISBRG Corp

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Alan Forster

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rae Lake, MD

Role: PRINCIPAL_INVESTIGATOR

ISBRG Corp

Locations

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COVID-19 CHEO Assessment Centre

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

COVID-19 Assessment Centre for Adults

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Alison Jennings

Role: CONTACT

6137985555 ext. 19717

Austin MacIntyre

Role: CONTACT

Facility Contacts

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Nadine Drosdowech

Role: primary

Cassie Matthews

Role: primary

Other Identifiers

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20210902

Identifier Type: -

Identifier Source: org_study_id

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