Bioaerosol Sampling Device (BSD) Clinical Study

Last updated: September 14, 2023
Sponsor: Cantor BioConnect, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT06047067
CBC-1051
  • Ages > 5
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be tested for COVID-19.

Eligibility Criteria

Inclusion

Inclusion Criteria: Any patient 5 years or older who wants to be tested Patients may be symptomatic orasymptomatic based on CDC guidelines Patients may be suspected of having COVID-19 based onCDC guidelines Patient's COVID-19 status should be unknown Patients younger than 12 shouldbe assisted by an adult

Exclusion

Exclusion Criteria: Unable to self-consent Concurrent enrollment in other trials involving same-day nasalcavity sampling Contraindication to nasal sampling as performed according to the clinical site policies andprocedures, including: Unable to tolerate Nasal Swab Sampling History of perforation of the nasal septum or proneto nosebleed Head or facial injury/surgery within the past 6 months On anticoagulanttherapy including anti-platelet therapy Nasal or nasal aspirate and nasal wash performed asstandard of care.

Study Design

Total Participants: 330
Study Start date:
July 10, 2023
Estimated Completion Date:
May 19, 2024

Study Description

SARS-CoV-2, the virus which causes COVID-19, is transmissible through bioaerosols. Routine accessible, non-invasive, sensitive testing could play a role in reducing the spread of the disease and controlling the current and future pandemics. The Bioaerosol Sampling Device may offer both comfort and the potential to increase the ability to detect patients earlier in the infection cycle than a swab. The primary objective of the research is to generate BSD performance data with detection by RT-PCR and at-home molecular and antigen assays, compared to nasal swab comparator detected by EUA or 510k cleared RT-PCR.

Connect with a study center

  • JPRA Enterprise, LLC

    S. Gate, California 90280
    United States

    Active - Recruiting

  • Alfa Medical Research

    Hollywood, Florida 33204
    United States

    Active - Recruiting

  • Alfa Medical Urgent Care

    Pembroke Pines, Florida 33029
    United States

    Active - Recruiting

  • HDH Research

    Houston, Texas 77009
    United States

    Active - Recruiting

  • HDH Research

    Humble, Texas 77338
    United States

    Active - Recruiting

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