Kenota 1 CWS Method Comparison Validation Study
Public ClinicalTrials.gov record NCT05702671. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Validation Study of Point of Care Kenota 1 System and Total Immunoglobulin E Test Kit Using the CWS Method Comparison Validation Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05702671
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 411 participants
Conditions and interventions
Interventions
- Total Immunoglobulin E, Obtained From Fingerstick Sample Diagnostic Test
Diagnostic Test
Eligibility (public fields only)
- Age range
- Up to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 26, 2023
- Primary completion
- Apr 6, 2023
- Completion
- Apr 6, 2023
- Last update posted
- May 5, 2023
2023
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Paul Allergy & Asthma | Saint Paul | Minnesota | 55116 | — |
| Allergy Partners of Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Children's Specialty Group | Virginia Beach | Virginia | 23456 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05702671, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2023 · Synced Sep 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05702671 live on ClinicalTrials.gov.