NCT03777098

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 426 (actual)
• Sponsor: David A. Talan · Academic / Other
• Sex: All
• Age: 7 Years – 64 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-01-02
• Primary completion: 2021-11-30
• Completion: 2021-12-30
• First posted: 2018-12-17
• Last updated: 2022-04-20

Locations

1 site across 1 country: United States