Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 20
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test
详细描述
The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to provide written informed consent.
- •Participant is a female aged 14 to 50 years old at time of consent.
- •Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis
排除标准
- •Participant is a female in a pre-menarchal state.
- •Participant is pregnant.
- •Participant has an active malignancy.
- •Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
- •Participant has an active pelvic infection or other infections contraindicated for surgery.
- •Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
- •Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
- •Participant is under 14 years old or over 50 years old
结局指标
主要结局
Sensitivity and Specificity
时间窗: 24 months
The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively
次要结局
- Performance(24 months)