ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study

NCT01881711 | Unknown Phase 4 DMC

• 2 other identifiers: NDxDev-SCMP-2013R44NS067772
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Suspected CSF Shunt Obstruction

Keywords

hydrocephalus; CSF shunt; shunt malfunction; shunt obstruction; ShuntCheck; ShuntCheck-Micro-Pumper

Outcome Measures

Primary Outcomes (4)

• Diagnostic accuracy compared with clinical outcomes

  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.

  7 days

• Positive Predictive Value (PPV)

  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.

  7 days

• Negative Predictive Value (NPV)

  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.

  7 days

• Safety

  To determine if any adverse events were caused by the device or procedure while using the study device.

  1 day

Secondary Outcomes (2)

• Rule Out for Low Risk Cases

  7 days

• Increased PPV and NPV for Uncertain Cases

  7 days

Study Arms (6)

SCMP plus Imaging

EXPERIMENTAL

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.

Device: ShuntCheck-Micro-Pumper (SCMP); Device: Imaging

Imaging Alone

ACTIVE COMPARATOR

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.

Device: Imaging

SCMP Rule Out for Low Risk Cases

EXPERIMENTAL

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

Device: ShuntCheck-Micro-Pumper (SCMP)

Imaging Rule for Low Risk Cases

ACTIVE COMPARATOR

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

Device: Imaging

SCMP plus Imaging in Uncertain Cases

EXPERIMENTAL

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

Device: ShuntCheck-Micro-Pumper (SCMP); Device: Imaging

Imaging alone in Uncertain Cases

ACTIVE COMPARATOR

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

Device: Imaging

Interventions

ShuntCheck-Micro-Pumper (SCMP) DEVICE

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.

SCMP Rule Out for Low Risk Cases; SCMP plus Imaging; SCMP plus Imaging in Uncertain Cases

Imaging DEVICE

Imaging of ventricle size

Also known as: CT Scan, MRI

Imaging Alone; Imaging Rule for Low Risk Cases; Imaging alone in Uncertain Cases; SCMP plus Imaging; SCMP plus Imaging in Uncertain Cases

Eligibility Criteria

• Age: 35 Months - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeuroDx Development: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (11)

A I dePont Hospital for Children

Wilmington, Delaware, 19803, United States

RECRUITING

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Chicago Comer Children's Hospital

Chicago, Illinois, 60637, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Stony Brook Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas-Houston/Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Interventions

Diagnostic Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Joseph R Madsen, MD

  Boston Children's Hospital

  STUDY CHAIR

• George I Jallo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• David A Frim, MD

  University of Chicago Comer Children's Hospital

  PRINCIPAL INVESTIGATOR

• David Sandberg, MD

  University of Texas-Houston/Children's Memorial Hermann Hospital

  PRINCIPAL INVESTIGATOR

• Phillip B Storm, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Joseph J Zorc, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Robert W Hickey, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Mandeep Tamber, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Lisa H Merck, MD MPH

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Petra M Klinge, MD PhD

  Rhode Isalnd Hospital

  PRINCIPAL INVESTIGATOR

• Robert F Keating, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• James Chamberlain, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Jeffrey R Leonard, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Julie C Leonard, MD MPH

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Joseph H Piatt, MD

  Alfred I. duPont Hospital for Children

  PRINCIPAL INVESTIGATOR

• Jonathan E Bennett, MD

  Alfred I. duPont Hospital for Children

  PRINCIPAL INVESTIGATOR

• David Chesler, MD

  Stony Brook Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph R Madsen, MD

CONTACT

617) 355-6005; Joseph.Madsen@childrens.harvard.edu

Eun-Hyoung Park

CONTACT

617.355.6558; Eun-Hyoung.Park@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 20, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (11)