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NCT Number: NCT05918354

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

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Universitaires Saint-Luc, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Prick Automated Test

Device

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

Primary outcomes

  1. Equivalency of S.P.A.T. artificial intelligence versus physician

    Time frame: 15 minutes after the diagnostic test

    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.

Secondary outcomes

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

    Time frame: 15 minutes after the diagnostic test

    Likelihood that the S.P.A.T. AI maximal wheal diameter measurement lays within the range of the maximal wheal size measurement of 3 independent physicians.

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

    Time frame: 15 minutes after the diagnostic test

    Variation in maximal wheal size diameter of the same image by 3 independent physicians.

  3. Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician

    Time frame: 15 minutes after the diagnostic test

    Accuracy of the maximal wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.

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

    Time frame: 15 minutes after the diagnostic test

    Inter-reader variability of read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.

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

    Time frame: 15 minutes after the diagnostic test

    Total time required to perform read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone.

  6. Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician

    Time frame: 15 minutes after the diagnostic test

    Accuracy of mean wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.

  7. Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician

    Time frame: 15 minutes after the diagnostic test

    Accuracy of wheal area by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.

  8. Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician

    Time frame: 15 minutes after the diagnostic test

    Accuracy of HEP-index measurement by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.

Sponsors and collaborators

Lead sponsor

Hippocreates

Industry

Registry information

Official study title

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

Acronym: SPAT_AI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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