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Physician Preference Study of ShuntCheck - Madsen

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583336
Recruitment Status : Unknown
Verified June 2015 by NeuroDx Development.
Recruitment status was:  Recruiting
First Posted : December 31, 2007
Last Update Posted : June 23, 2015
Boston Children’s Hospital
Information provided by (Responsible Party):
NeuroDx Development

Brief Summary:

ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.

Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)

Condition or disease Intervention/treatment
CSF Flow Through the Shunt of a Hydrocephalus Patient Device: ShuntCheck

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
Study Start Date : September 2007
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Diagnostic Device: ShuntCheck
Thermal dilution test for CSF flow

Primary Outcome Measures :
  1. ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested [ Time Frame: Tested in single visit ]

Secondary Outcome Measures :
  1. ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction [ Time Frame: Single visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
  2. Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
  3. Subjects must be physically stable as determined by the physician.

Exclusion Criteria:

  1. Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
  2. Subjects unable to lie supine with head elevated 30 degrees or less
  3. Subjects who have had shunt surgery within two weeks.
  4. Inability or unwillingness of subject to endure the test.
  5. Other judgments of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583336

Contact: Joseph R Madsen, MD (617) 355-6005

United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Joseph R Madsen, MD         
Sponsors and Collaborators
NeuroDx Development
Boston Children’s Hospital
Principal Investigator: Joseph R Madsen, MD Boston Children’s Hospital

Responsible Party: NeuroDx Development Identifier: NCT00583336     History of Changes
Other Study ID Numbers: NDX 07-07-0277
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases