An Operator-Blinded Study of the Efficacy of ShuntCheck-Micro-Pumper, a Non-Invasive Diagnostic Procedure, in Detecting Ventricular Shunt Patency or Occlusion and in Predicting Clinical Outcome in Children and Adolescents Presenting to Emergency Departments and Neurosurgery Clinics
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 22
- 主要终点
- Diagnostic accuracy compared with clinical outcomes
研究概览
简要总结
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects presenting to an Emergency Department or Neurosurgery Clinic (ED/NC). SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Months 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, older than 35 months and less than 20 years of age.
- •Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required.
- •Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.
- •Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition
- •Will be available for follow-up for up to 7 days
排除标准
- •Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.
- •Presence of multiple shunts or known non-functioning shunts crossing the clavicle.
- •Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.
- •SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.
- •Presence of an interfering open wound or edema over the shunt.
- •Likelihood, in the judgment of the investigator, of the subject being lost to follow-up as a result of subject unavailability or clinical outcome being unobtainable.
- •Any other condition that would preclude or bias the results of the study according to the judgment of the investigator.
- •Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.
结局指标
主要结局
Diagnostic accuracy compared with clinical outcomes
时间窗: 7 days
SCMP results and SCMP results combined with other diagnostic methods, including the Attending Physician's and the Neurosurgeon's clinical judgment will be compared to clinical outcomes within 7 days of ED/NC visit - either shunt obstruction confirmed during shunt revision surgery or shunt patency confirmed by no surgery or patency confirmed in surgery.
Positive Predictive Value (PPV)
时间窗: 7 days
Specifically to demonstrate that SCMP positive (Flow Not Confirmed - FNC) plus imaging positive (enlarged ventricles) results yield a higher positive predictive value than imaging positive alone.
Negative Predictive Value (NPV)
时间窗: 7 days
Specifically to demonstrate that SCMP negative (Flow Confirmed - FC) plus imaging negative (non-enlarged ventricles) results yield a higher negative predictive value than imaging negative alone.
Safety
时间窗: 1 day
To determine if any adverse events were caused by the device or procedure while using the study device.
次要结局
- Rule Out for Low Risk Cases(7 days)
- Increased PPV and NPV for Uncertain Cases(7 days)