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Kenota 1 CWS Method Comparison Validation Study

NCT05702671 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2023-05-06

No results posted yet for this study

Summary

The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods. The main questions it aims to answer are:

* Are the Kenota 1 Devices easy to use by untrained operators at a clinic environment?
* Do tIgE results provided by the Kenota 1 Devices match the results provided by the FDA-cleared Phadia ImmunoCAP System?

Subjects will be asked to donate two fingerstick whole blood samples and one venous blood draw.

Conditions

  • Allergy
  • Immunoglobulin E-Mediated Allergic Disorder

Interventions

DIAGNOSTIC_TEST

Total Immunoglobulin E, Obtained From Fingerstick Sample

The Kenota 1 System is intended to be a specialized tool in a professional allergist setting. It will help streamline the patient testing process by bringing quantitative, minimally invasive fingerstick IgE blood testing to the allergy clinic.

Sponsors & Collaborators

  • Kenota Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Harder, PhD · Kenota Health

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-27
Primary Completion
2023-04-07
Completion
2023-04-07
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 NCT05702671 on ClinicalTrials.gov