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| Name | Class |
|---|---|
| Light AI Inc. | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strepic® Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Strepic Device Image | A picture of the participant's throat will be obtained at enrollment. | Day 1 |
| Throat culture or PCR result | The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings | Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting to participating U.S. emergency departments or clinics with complaint of pharyngitis will be screened.
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Moran, MD | Olive View-UCLA Education & Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Olive View-UCLA Medical Center | Sylmar | California | 91342 | United States |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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