AllergyNCT05702671
Kenota 1 CWS Method Comparison Validation Study
An observational study of Allergy and Immunoglobulin E-Mediated Allergic Disorder, run by Kenota Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy, Immunoglobulin E-Mediated Allergic Disorder
- What is being tested?
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- How many people
- 411 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2023to 7 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population will be selected from existing and new patients visiting the allergist clinic, as well as individuals from the clinic such as volunteering staff members.
Who may be able to join
- Ages <80 years
- From all Ethnic/Racial backgrounds
Who cannot join
- Individuals with skin damage, burns or scars at the site of venipuncture on both arms
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Allergy Partners of Chapel Hill
Chapel Hill, North Carolina, 27514
St. Paul Allergy & Asthma
Saint Paul, Minnesota, 55116
Children's Specialty Group
Virginia Beach, Virginia, 23456
About this study
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
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.
Read the detailed description
The Method Comparison Study will 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.
Arm (A): Fresh fingerstick whole blood will be collected and tested on Kenota 1 Devices at three CLIA-Waived sites (CWSs).
Arm (B): Venous plasma will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
Arm (C): Venous plasma will be collected at the CWSs and tested on Phadia instruments (ImmunoCAP) at the central lab site.
Arm (D): Venous whole blood will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
The first method for this study is the Kenota 1 System, which will be used across Three (3) U.S. CWSs. At each CWS, 120 subjects will be recruited and will be asked to donate fingerstick blood and venous blood.
Three (3) untrained operators at each site will be running the freshly collected fingerstick blood samples on the Kenota 1 Devices provided at the site (Testing Arm A). Site operators will also process and store the collected venous blood and venous plasma samples as instructed, and ship them to the central lab for further testing.
The second method for this study involves testing at a Central US Laboratory as a CLIA-regulated laboratory.
At the central lab, at least one trained lab operator will run frozen venous plasma (testing Arm B) and frozen venous whole blood (testing Arm D) collected from all subjects using the Kenota 1 Devices provided at the central lab. As the comparator method, one lab operator will run a second set of frozen plasma samples collected from all subjects on the Phadia ImmunoCAP System (testing Arm C).
The Method Comparison Validation Study is expected to be completed within two months and will be run in conjunction with the Multi-Site Reproducibility Validation Study. All testing will include a daily External Control session on each device used, ensuring the devices are performing as expected.
- Being tested
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- Keywords
- Point of Care, Total Immunoglobulin E (tIgE) level in blood, Fingerstick, Kenota 1 System, Kenota 1 Device, Allergy Clinics, Allergist
- Medical subject headings
- Hypersensitivity, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Immunoglobulin E, Obtained From Fingerstick SampleDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total IgE Value
Tests performed on the Kenota 1 Devices will provide tIgE values in kU/L for each test. These values will be compared directly with the tIgE results produced by the comparator method, Phadia ImmunoCAP system, which are also in kU/L.
The Slope, Intercept and Correlation Coefficient will be calculated and used to determine if overall proportional bias of Kenota 1 fresh fingerstick whole blood is less than 10% compared to the comparator method.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start27 Jan 2023
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenota Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Harder, PhD, Principal investigator, Kenota Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702671
- Sponsor's protocol ID
- DOC_K1M_0096
- Status last verified
- May 2023
- First submitted
- 8 Dec 2022
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No participant personal data will be shared. The information collected will only be in the Informed Consent Form and will be kept at the Site only for maximum of 3years
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05702671
- Acronym / sponsor ID
- DOC_K1M_0096
- Keywords
- Point of Care, Total Immunoglobulin E (tIgE) level in blood, Fingerstick, Kenota 1 System, Kenota 1 Device, Allergy Clinics, Allergist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Kenota Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Method Comparison Study will 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.
Arm (A): Fresh fingerstick whole blood will be collected and tested on Kenota 1 Devices at three CLIA-Waived sites (CWSs).
Arm (B): Venous plasma will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
Arm (C): Venous plasma will be collected at the CWSs and tested on Phadia instruments (ImmunoCAP) at the central lab site.
Arm (D): Venous whole blood will be collected at the CWSs and tested on Kenota 1 Devices at the central lab site.
The first method for this study is the Kenota 1 System, which will be used across Three (3) U.S. CWSs. At each CWS, 120 subjects will be recruited and will be asked to donate fingerstick blood and venous blood.
Three (3) untrained operators at each site will be running the freshly collected fingerstick blood samples on the Kenota 1 Devices provided at the site (Testing Arm A). Site operators will also process and store the collected venous blood and venous plasma samples as instructed, and ship them to the central lab for further testing.
The second method for this study involves testing at a Central US Laboratory as a CLIA-regulated laboratory.
At the central lab, at least one trained lab operator will run frozen venous plasma (testing Arm B) and frozen venous whole blood (testing Arm D) collected from all subjects using the Kenota 1 Devices provided at the central lab. As the comparator method, one lab operator will run a second set of frozen plasma samples collected from all subjects on the Phadia ImmunoCAP System (testing Arm C).
The Method Comparison Validation Study is expected to be completed within two months and will be run in conjunction with the Multi-Site Reproducibility Validation Study. All testing will include a daily External Control session on each device used, ensuring the devices are performing as expected.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be selected from existing and new patients visiting the allergist clinic, as well as individuals from the clinic such as volunteering staff members.
Key inclusion criteria (2 listed)
- Ages <80 years
- From all Ethnic/Racial backgrounds
Key exclusion criteria (1 listed)
- Individuals with skin damage, burns or scars at the site of venipuncture on both arms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Immunoglobulin E, Obtained From Fingerstick SampleThe 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. | Diagnostic test | – |
Primary outcome
Total IgE Value
Time frame: One day
Tests performed on the Kenota 1 Devices will provide tIgE values in kU/L for each test. These values will be compared directly with the tIgE results produced by the comparator method, Phadia ImmunoCAP system, which are also in kU/L. The Slope, Intercept and Correlation Coefficient will be calculated and used to determine if overall proportional bias of Kenota 1 fresh fingerstick whole blood is less than 10% compared to the comparator method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No. No participant personal data will be shared. The information collected will only be in the Informed Consent Form and will be kept at the Site only for maximum of 3years
Related trials for Allergy
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruiting
Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children
Active, not recruitingObservational study
Study on the Impact of Different Feeding Methods on Allergy Prevention and Digestive Absorption in Infants and Young Children
Infant Allergy, Infant Gut Health
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Harder, PhD principal investigator
Kenota Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy and Immunoglobulin E-Mediated Allergic Disorder, run by Kenota Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total IgE Value (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.