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

NCT05918354 | Completed

• 1 other identifier: HDX003
• Study Type: observational
• Target: 993
• Locations: 2 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes after the diagnostic test

Secondary Outcomes (8)

• Precision of S.P.A.T. artificial intelligence versus physician

  15 minutes after the diagnostic test

• Intra-reader variability of S.P.A.T. read out by physicians

  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

  15 minutes after the diagnostic test

• Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician

  15 minutes after the diagnostic test

• Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician

  15 minutes after the diagnostic test

Study Arms (1)

Allergy

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

Device: Skin Prick Automated Test

Interventions

Skin Prick Automated Test DEVICE

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

Allergy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hippocreates: lead

Study Sites (6)

Clinique Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

GZA ziekenhuizen

Wilrijk, 2610, Belgium

Location

Klinikum rechts der Isar

Munich, 81675, Germany

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Mark Jorissen, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 10, 2023
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

DE (1); BE (5)