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Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis

NCT03777098 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 426

Last updated 2022-04-20

No results posted yet for this study

Summary

The objective of this pilot study is to acquire images using the Strepic® device, a clinical prototype that has been designed specifically as a viable, low-cost, commercially realizable autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image data, as well as other clinical data points. By acquiring and analyzing the images of pharyngeal bacterial fluorescence and white light patterns in patients with Group A Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS pharyngitis, it is believed an algorithm can be developed such that the device will improve the ability of clinicians to quickly and accurately identify GAS infections.

Conditions

  • Group A Streptococcal Infection

Interventions

DEVICE

Strepic® Device

The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.

Sponsors & Collaborators

  • Light AI, Inc.

    collaborator UNKNOWN

  • David A. Talan

    lead OTHER

Principal Investigators

  • Gregory Moran, MD · Olive View-UCLA Education & Research Institute

Eligibility

Min Age
7 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2021-11-30
Completion
2021-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777098 on ClinicalTrials.gov