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Rutgers Pilot for PREDICT- Patient POC Test

NCT05612724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-03-27

Study results available
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Summary

A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test.

14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures.

Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test.

Conditions

  • SARS CoV 2 Infection

Interventions

DEVICE

Testing for SARS CoV2 Antigen

Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Cecile A Feldman · Rutgers School of Dental Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2021-01-20
Completion
2022-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05612724 on ClinicalTrials.gov