Clinical trial NCT05918354: Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Lead sponsor: Hippocreates
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 993
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.

Exclusion Criteria:

* 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)
* Incapacitated individuals
* Individuals who do not speak the local language (Dutch - French)
* Individuals who cannot read or write

Primary outcomes:
measure: Equivalency of S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
Secondary outcomes:
measure: Precision of S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Intra-reader variability of S.P.A.T. read out by physicians
timeFrame: 15 minutes after the diagnostic test
measure: Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
measure: Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
timeFrame: 15 minutes after the diagnostic test
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique Universitaires Saint-Luc
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Wilrijk
country: Belgium
facility: GZA ziekenhuizen
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: UZ Leuven
name: Mark Jorissen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: