Recruiting

Bioaerosol Sampling Device

Sponsor:

Cantor BioConnect, Inc.

Code:

NCT06047067

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

COVID-19

Study ID

NCT06047067

Start date

Jul 10, 2023

Status verified date

Sep, 2023

Completion date

May 19, 2024

Anticipated

Primary completion date

May 19, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

Unable to self-consent Concurrent enrollment in other trials involving same-day nasal cavity sampling

Contraindication to nasal sampling as performed according to the clinical site policies and procedures, including:

Unable to tolerate Nasal Swab Sampling History of perforation of the nasal septum or prone to nosebleed Head or facial injury/surgery within the past 6 months On anticoagulant therapy including anti-platelet therapy Nasal or nasal aspirate and nasal wash performed as standard of care.

Study Design

Enrollment

330 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • BSD detection of SARS-CoV-2: 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. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Study Cooridnator

(619) 635-5843emerald@cantorbioconnect.com

Locations

JPRA Enterprise, LLC

Recruiting

S. Gate, California, United States, 90280

Contacts

Robert Azurin, MD

562-547-1799

Alfa Medical Research

Recruiting

Hollywood, Florida, United States, 33204

Contacts

Ausberto Hidalgo, MD

754-263-3626

Alfa Medical Urgent Care

Recruiting

Pembroke Pines, Florida, United States, 33029

HDH Research

Recruiting

Houston, Texas, United States, 77009

HDH Research

Recruiting

Houston, Texas, United States, 77022

Contacts

Francisco Ortiz, MD

346-282-4426

HDH Research

Recruiting

Humble, Texas, United States, 77338

More Information

Sponsor

Cantor BioConnect, Inc.

Last update posted

Sep 21, 2023

Last verified

Sep, 2023

Keywords

  • COVID-19
  • Rapid diagnostic test
  • SARS-CoV-2
  • SARS-CoV-1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cantor BioConnect, Inc. on 2023-09-21.