Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT06047067
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioaerosol Sampling Device (BSD) Clinical Study
Sponsor:
Cantor BioConnect, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: