Recruiting

ShuntCheck

Sponsor:

NeuroDx Development

Code:

NCT01881711

Conditions

Suspected CSF Shunt Obstruction

Eligibility Criteria

Sex: All

Age: 2 - 29

Healthy Volunteers: Not accepted

Interventions

ShuntCheck-Micro-Pumper (SCMP)

Imaging

Study Details

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

Study ID

NCT01881711

Start date

May, 2013

Status verified date

Jun, 2015

Completion date

Sep, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 29

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: SCMP plus Imaging

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.

active comparator: Imaging Alone

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.

experimental: SCMP Rule Out for Low Risk Cases

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

active comparator: Imaging Rule for Low Risk Cases

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

experimental: SCMP plus Imaging in Uncertain Cases

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

active comparator: Imaging alone in Uncertain Cases

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

Interventions

ShuntCheck-Micro-Pumper (SCMP)

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.

Imaging

Imaging of ventricle size

Primary outcome measure

  • Diagnostic accuracy compared with clinical outcomes [ Time Frame: 7 days ]
  • Positive Predictive Value (PPV) [ Time Frame: 7 days ]
  • Negative Predictive Value (NPV) [ Time Frame: 7 days ]
  • Safety [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

A I dePont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Principal Investigator:

Joseph H Piatt, MD

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Principal Investigator:

Robert F Keating, MD

University of Chicago Comer Children's Hospital

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

David Frim, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

George I Jallo, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Joseph R Madsen, MD

Stony Brook Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Principal Investigator:

David Chesler, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Principal Investigator:

Jeffrey R Leonard, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Phillip B Storm, MD

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Lisa H Merck, MD MPH

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

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

David Sandberg, MD

More Information

Sponsor

NeuroDx Development

Last update posted

Jun 23, 2015

Last verified

Jun, 2015

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NeuroDx Development on 2015-06-23.