An observational study in Allergy, sponsored by Hippocreates. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Hippocreates · Observational
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.
1,925 studies on the registry are indexed under Hypersensitivity; 261 are open to participants now.
This study's enrollment of 993 is above the median of 113 across 482 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Hippocreates is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
Exclusion Criteria:
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
Detection of sensitisation to specific allergens via the skin prick automated test.
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.
Time frame: 15 minutes after the diagnostic test
Precision of S.P.A.T. artificial intelligence versus physician
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.
Time frame: 15 minutes after the diagnostic test
Intra-reader variability of S.P.A.T. read out by physicians
Variation in maximal wheal size diameter of the same image by 3 independent physicians.
Time frame: 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
Accuracy of the maximal wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Time frame: 15 minutes after the diagnostic test
Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician
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.
Time frame: 15 minutes after the diagnostic test
Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician
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.
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of mean wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of wheal area by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Time frame: 15 minutes after the diagnostic test
Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician
Accuracy of HEP-index measurement by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician.
Time frame: 15 minutes after the diagnostic test
Plan to share: Undecided
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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