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Physician Preference Study of ShuntCheck - Madsen

This study is currently recruiting participants.
Verified June 2013 by NeuroDx Development
Sponsor:
Collaborator:
Children's Hospital Boston
Information provided by (Responsible Party):
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT00583336
First received: December 20, 2007
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention
CSF Flow Through the Shunt of a Hydrocephalus Patient
 Device: ShuntCheck

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by NeuroDx Development:

Primary Outcome Measures:
  • ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested [ Time Frame: Tested in single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic Device: ShuntCheck
Thermal dilution test for CSF flow

  Eligibility

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583336

Contacts
Contact: Joseph R Madsen, MD (617) 355-6005 Joseph.Madsen@childrens.harvard.edu

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

No publications provided

Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT00583336     History of Changes
Other Study ID Numbers: NDX 07-07-0277, 07-07-0277
Study First Received: December 20, 2007
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on June 18, 2013