Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies (SPAT_AI)

Hippocreates

Status: Completed

Conditions: Allergy

Treatments: Device: Skin Prick Automated Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05918354

HDX003

Details and patient eligibility

About

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.

Enrollment: 993 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

993 participants in 1 patient group

Allergy

Description:

Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens with skin prick automated test device.

Treatment:

Device: Skin Prick Automated Test