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COMPLETED

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

NCT03777098 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE Strepic® Device

Study Locations (1)

California

  • Olive View-UCLA Medical Center — Sylmar

Trial Details

FieldValue
Enrollment Target 426 participants
Start Date 2019-01-02
Est. Completion 2021-12-30

Sponsor

David A. Talan

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03777098

The ClinicalTrials.gov registry entry for NCT03777098 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 426 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is David A. Talan, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Group A Streptococcal Infection appearing as the primary indexed condition, and to 1 intervention — of which Strepic® Device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03777098 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03777098 about?

NCT03777098 is a clinical study titled "Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis". 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 cl...

What is the current status of trial NCT03777098?

This trial is currently completed. The enrollment target is 426 participants. The study started on 2019-01-02. Estimated completion is 2021-12-30.

What conditions does trial NCT03777098 study?

This clinical trial studies the following conditions: Group A Streptococcal Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03777098?

The interventions under investigation include: Strepic® Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03777098?

This trial is sponsored by David A. Talan, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03777098 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial