NCT06047067

Bioaerosol Sampling Device (BSD) Clinical Study

BIOAEROSOL SAMPLING DEVICE (BSD) CLINICAL STUDY: Performance of Respiratory Pathogen Bioaerosol Sampling Device Compared to Matched Swab Sample With Molecular and Antigen Assays That Can Detect SARS-CoV-2 Phase II Validation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 330 (estimated)
• Sponsor: Cantor BioConnect, Inc. · Network
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-05-19
• Completion: 2024-05-19
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

6 sites across 1 country: United States