AllergySPAT_AINCT05918354
Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies
An observational study of Allergy, run by Hippocreates at 6 sites in 2 countries.
Trial summary
To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Skin Prick Automated Test
- Type of treatment
- Medical device
- How many people
- 993 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 10 Jul 2023to 11 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Who may be able to join
- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Who cannot join
- Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
- Use of antihistaminic medication < 7 days before the start of the study
- Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
- Use of topical corticoids on the forearm < 7 days before the start of the study
- Use of Omalizumab < 6 months before the start of the study
- Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)
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- Incapacitated individuals
- Individuals who do not speak the local language (Dutch - French)
- Individuals who cannot read or write
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Belgium5 sites
Clinique Universitaires Saint-Luc
Brussels, 1200
Ziekenhuis Oost Limburg
Genk, 3500
UZ Leuven
Leuven, 3000
CHU de Liège
Liège, 4000
GZA ziekenhuizen
Wilrijk, 2610
About this study
Official title: Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies
To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test.
In this study 700 images will be collected to develop the AI model, an additional 200 images will be collected to evaluate performance of the AI model. In a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the S.P.A.T. AI medical software.
Read more
The primary endpoint is the accuracy of the maximal wheal size measurement by S.P.A.T. AI versus the maximal wheal size measurement by the physician.
It is a prospective multicentric study that will include 1000 study participants from different countries.
- Conditions
- Allergy
- Being tested
- Skin Prick Automated Test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prick Automated TestDevice
Detection of sensitisation to specific allergens via the skin prick automated test.
| Study group | Role | What they receive |
|---|---|---|
| Allergy | Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens with skin prick automated test device. Receives: Device: Skin Prick Automated Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalency of S.P.A.T. artificial intelligence versus physician
The equivalency of the maximal wheal diameter as measured by S.P.A.T. AI versus the maximal wheal diameter as assessed by the physician.
Measured: 15 minutes after the diagnostic test
Secondary outcomes (8)
Precision of S.P.A.T. artificial intelligence versus physician
Likelihood that the S.P.A.T. AI maximal wheal diameter measurement lays within the range of the maximal wheal size measurement of 3 independent physicians.
Measured: 15 minutes after the diagnostic test
Intra-reader variability of S.P.A.T. read out by physicians
Variation in maximal wheal size diameter of the same image by 3 independent physicians.
Measured: 15 minutes after the diagnostic test
Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of the maximal wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Measured: 15 minutes after the diagnostic test
Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician
Inter-reader variability of read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.
Measured: 15 minutes after the diagnostic test
Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician
Total time required to perform read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.
Measured: 15 minutes after the diagnostic test
Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of mean wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Measured: 15 minutes after the diagnostic test
Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of wheal area by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Measured: 15 minutes after the diagnostic test
Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of HEP-index measurement by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Measured: 15 minutes after the diagnostic test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start10 Jul 2023
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
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
- Prospective
- Enrolment
- 993 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocreates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Jorissen, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918354
- Sponsor's protocol ID
- HDX003
- Acronym
- SPAT_AI
- Status last verified
- Oct 2024
- First submitted
- 15 Jun 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies
- ClinicalTrials.gov ID
- NCT05918354
- Acronym / sponsor ID
- SPAT_AI / HDX003
- Conditions
- Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 993 participants (actual)
- Lead sponsor
- HippocreatesIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 26 Jun 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.
To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test.
In this study 700 images will be collected to develop the AI model, an additional 200 images will be collected to evaluate performance of the AI model. In a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the S.P.A.T. AI medical software.
The primary endpoint is the accuracy of the maximal wheal size measurement by S.P.A.T. AI versus the maximal wheal size measurement by the physician.
It is a prospective multicentric study that will include 1000 study participants from different countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergy | – | Device: Skin Prick Automated TestAdults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens with skin prick automated test device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Key inclusion criteria (1 listed)
- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Key exclusion criteria (9 listed)
- Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
- Use of antihistaminic medication < 7 days before the start of the study
- Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
- Use of topical corticoids on the forearm < 7 days before the start of the study
- Use of Omalizumab < 6 months before the start of the study
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 |
|---|---|---|
| Skin Prick Automated TestDetection of sensitisation to specific allergens via the skin prick automated test. | Device | Allergy |
Primary outcome
Equivalency of S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
The equivalency of the maximal wheal diameter as measured by S.P.A.T. AI versus the maximal wheal diameter as assessed by the physician.
8 secondary outcomes
Precision of S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
Intra-reader variability of S.P.A.T. read out by physicians
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician
Time frame: 15 minutes after the diagnostic test
Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Time frame: 15 minutes after the diagnostic test
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 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Mark Jorissen, MD, PhD principal investigator
UZ Leuven
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Hippocreates at 6 sites in 2 countries.
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 1 inclusion and 9 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany. 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?
Equivalency of S.P.A.T. artificial intelligence versus physician (time frame: 15 minutes after the diagnostic test). 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 16 Oct 2024.