Kenota 1 CWS Method Comparison Validation Study

Completed

Conditions studied: Allergy, Immunoglobulin E-Mediated Allergic Disorder

In brief

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.

Key facts

Study ID

NCT05702671

Run by

Kenota Inc.

People needed

411

Starts

2023-01-27

Expected to finish

2023-04-07

Last updated by the study team

2023-05-06

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages <80 years
• From all Ethnic/Racial backgrounds

You may not qualify if…

• Individuals with skin damage, burns or scars at the site of venipuncture on both arms

Where it is running

• St. Paul Allergy & Asthma — Saint Paul, Minnesota, United States
• Allergy Partners of Chapel Hill — Chapel Hill, North Carolina, United States
• Children's Specialty Group — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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