NCT05918354

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

Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 993 (actual)
• Sponsor: Hippocreates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Skin Prick Automated Test	Detection of sensitisation to specific allergens via the skin prick automated test.

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-09-11
• Completion: 2024-09-11
• First posted: 2023-06-26
• Last updated: 2024-10-16

Locations

6 sites across 2 countries: Belgium, Germany