ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

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

Patrocinadores

Patrocinador principal: NeuroDx Development

Colaborador: National Institute of Neurological Disorders and Stroke (NINDS)

Fuente NeuroDx Development
Resumen breve

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.

Estado general Unknown status
Fecha de inicio May 2013
Fecha de Terminación September 2015
Fecha de finalización primaria June 2015
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Diagnostic accuracy compared with clinical outcomes 7 days
Positive Predictive Value (PPV) 7 days
Negative Predictive Value (NPV) 7 days
Safety 1 day
Resultado secundario
Medida Periodo de tiempo
Rule Out for Low Risk Cases 7 days
Increased PPV and NPV for Uncertain Cases 7 days
Inscripción 400
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: ShuntCheck-Micro-Pumper (SCMP)

Descripción: ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow "downstream" of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck.

Tipo de intervención: Device

Nombre de intervención: Imaging

Descripción: Imaging of ventricle size

Elegibilidad

Criterios:

Inclusion Criteria:

1. Males or females, older than 35 months and less than 20 years of age.

2. 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.

3. Possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle.

4. Suspicion of shunt obstruction is great enough to warrant the performance of any diagnostic test for this condition

5. Will be available for follow-up for up to 7 days

Exclusion Criteria:

1. Inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the Institutional Review Board.

2. Presence of multiple shunts or known non-functioning shunts crossing the clavicle.

3. Evaluating staff rule out shunt obstruction on the basis of a physical/clinical examination.

4. SCMP test would interfere with emergent subject care or if the subject is scheduled to go the OR in short order.

5. Presence of an interfering open wound or edema over the shunt.

6. 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.

7. Any other condition that would preclude or bias the results of the study according to the judgment of the investigator.

8. Judgment of the investigator that participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject.

Género: All

Edad mínima: 35 Months

Edad máxima: 29 Years

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Joseph R Madsen, MD

Teléfono: 617) 355-6005

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador:
A I dePont Hospital for Children | Wilmington, Delaware, 19803, United States Recruiting Jonathan E Bennett, MD 301-651-5827 [email protected] Joseph H Piatt, MD Principal Investigator Jonathan E Bennett, MD Principal Investigator
Children's National Medical Center | Washington, District of Columbia, 20010, United States Recruiting Ashley Simmons 301-565-4288 [email protected] Robert F Keating, MD Principal Investigator James Chamberlain, MD Principal Investigator
University of Chicago Comer Children's Hospital | Chicago, Illinois, 60637, United States Recruiting David Frim, MD 773-702-2475 [email protected] David Frim, MD Principal Investigator
Johns Hopkins Hospital | Baltimore, Maryland, 21287, United States Recruiting George I Jallo, MD 410-955-7851 [email protected] George I Jallo, MD Principal Investigator
Boston Children's Hospital | Boston, Massachusetts, 02115, United States Recruiting Joseph R Madsen, MD 617-355-6005 [email protected] Joseph R Madsen, MD Principal Investigator
Stony Brook Medical Center | Stony Brook, New York, 11794, United States Recruiting Alina Stroia 631-632-9028 [email protected] David Chesler, MD Principal Investigator
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Recruiting Julie C Leonard, MD 631-444-1213 [email protected] Jeffrey R Leonard, MD Principal Investigator Julie C Leonard, MD MPH Principal Investigator
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Recruiting Phillip B Storm, MD 215-590-2780 [email protected] Phillip B Storm, MD Principal Investigator Joseph J Zorc, MD Principal Investigator
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15224, United States Recruiting Robert W Hickey, MD 412-692-5052 [email protected]
Rhode Island Hospital | Providence, Rhode Island, 02903, United States Recruiting Blanche Spindell 401-444-2328 [email protected] Lisa H Merck, MD MPH Principal Investigator Petra M Klinge, MD PhD Principal Investigator
University of Texas-Houston/Children's Memorial Hermann Hospital | Houston, Texas, 77030, United States Recruiting David Sandberg, MD 713-500-7306 [email protected] David Sandberg, MD Principal Investigator
Ubicacion Paises

United States

Fecha de verificación

June 2015

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Número de brazos 6
Grupo de brazo

Etiqueta: SCMP plus Imaging

Tipo: Experimental

Descripción: SCMP plus Imaging 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.

Etiqueta: Imaging Alone

Tipo: Active Comparator

Descripción: Imaging alone 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.

Etiqueta: SCMP Rule Out for Low Risk Cases

Tipo: Experimental

Descripción: SCMP results in patients judged by the physician to be "Unlikely to require shunt surgery" 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 - to determine Negative Predictive Value in ruling out shunt malfunction

Etiqueta: Imaging Rule for Low Risk Cases

Tipo: Active Comparator

Descripción: Imaging results in patients judged by the physician to be "Unlikely to require shunt surgery" 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 - to determine Negative Predictive Value in ruling out shunt malfunction

Etiqueta: SCMP plus Imaging in Uncertain Cases

Tipo: Experimental

Descripción: SCMP plus imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" 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 - to determine Positive and Negative Predictive Value

Etiqueta: Imaging alone in Uncertain Cases

Tipo: Active Comparator

Descripción: Imaging results in patients who are admitted for observation results in patients judged by the physician to be "Unlikely to require shunt surgery" 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 - to determine Positive and Negative Predictive Value

Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Diagnostic

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov