Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hippocreates
- 入组人数
- 993
- 试验地点
- 6
- 主要终点
- Equivalency of S.P.A.T. artificial intelligence versus physician
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included.
排除标准
- •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
结局指标
主要结局
Equivalency of S.P.A.T. artificial intelligence versus physician
时间窗: 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.
次要结局
- Intra-reader variability of S.P.A.T. read out by physicians(15 minutes after the diagnostic test)
- Precision of S.P.A.T. artificial intelligence 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)
- Comparison of different methods (mean - 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)
- Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician(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 different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician(15 minutes after the diagnostic test)