SpotLight-19 Research & Development Study | NCT05198869

Studies
SpotLight-19 Research & Development Study

NCT05198869

Sponsor

Ottawa Hospital Research Institute

Status

Unknown status

Last Update Posted

Jan 20, 2022Actual

Enrollment

12,500Estimated

Phase

Not Applicable

Conditions

Screening

Interventions

Spectral scan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2021Actual

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

Jul 31, 2022Estimated

First Submitted Date

Dec 20, 2021

First Submission Date that Met QC Criteria

Jan 17, 2022

First Posted Date

Jan 20, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2022

Last Update Posted Date

Jan 20, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alan Forster, Principal Investigator, Ottawa Hospital Research InstitutePrincipal Investigator

Lead Sponsor

Ottawa Hospital Research InstituteOTHER

Collaborators

Name	Class
ISBRG Corp	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spectral scan (All participants)	Other	Fitzpatrick skin assessment. 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. 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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spectral scan	Device	Consenting participants will have a SpotLight-19 scan	Spectral scan (All participants)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alison Jennings	Contact	6137985555	19717	ajennings@ohri.ca
Austin MacIntyre	Contact			amacintyre@isbrgcorp.com

Overall Officials

Name	Affiliation	Role
Rae Lake, MD	ISBRG Corp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
COVID-19 CHEO Assessment Centre	Not yet recruiting	Ottawa	Ontario	K1S 5T1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided