Cognoa ASD Diagnosis Aid Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cognoa, Inc.
- 入组人数
- 711
- 试验地点
- 29
- 主要终点
- Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
研究概览
简要总结
The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.
详细描述
To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All participants and healthcare providers will be blinded to the diagnosis results.
入排标准
- 年龄范围
- 18 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
- •Caregiver or HCP concern for developmental delay.
- •Female or Male, >18 to <72 months of age
排除标准
- •Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
- •Subjects whose age on the date of enrollment is outside the target age range.
- •Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.
结局指标
主要结局
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
时间窗: 6 Weeks
Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:
No Result Percentage
时间窗: 6 Weeks
Measurement of the percentage of children for whom the device has provided no result.
次要结局
- Device Sensitivity and Specificity(6 Weeks)