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

NCT ID: NCT05918354

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 993 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2024-09-11

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.

Conditions

Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Allergy

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

Skin Prick Automated Test

Intervention Type: DEVICE

Detection of sensitisation to specific allergens via the skin prick automated test.

Interventions

Skin Prick Automated Test

Detection of sensitisation to specific allergens via the skin prick automated test.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hippocreates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Jorissen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Clinique Universitaires Saint-Luc

Brussels, , Belgium

Ziekenhuis Oost Limburg

Genk, , Belgium

UZ Leuven

Leuven, , Belgium

CHU de Liège

Liège, , Belgium

GZA ziekenhuizen

Wilrijk, , Belgium

Klinikum rechts der Isar

Munich, , Germany

Countries

Belgium; Germany

Other Identifiers

HDX003

Identifier Type: -

Identifier Source: org_study_id