A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of virtopsy made completely
研究概览
简要总结
The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.
详细描述
Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings.
Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stillbirth and fetal deaths over 21 weeks of gestation
- •termination of pregnancy over 21 weeks of gestation
- •neonatal death
- •patient having read the letter of information and signed the consent.
排除标准
- •legal incapacity
- •limited ability to consent
- •lack of parental consent
结局指标
主要结局
Number of virtopsy made completely
时间窗: month 12
Number of virtopsy made completely (from death until clinical report).
次要结局
未报告次要终点