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Physician Preference Study of ShuntCheck - Madsen

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by NeuroDx Development.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583336
First Posted: December 31, 2007
Last Update Posted: June 23, 2015
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.
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
NeuroDx Development
  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: 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

Resource links provided by NLM:


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 ]

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

Estimated Enrollment: 200
Study Start Date: September 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic Device: ShuntCheck
Thermal dilution test for CSF flow

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Boston Children’s Hospital
Investigators
Principal Investigator: Joseph R Madsen, MD Boston Children’s Hospital
  More Information

Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT00583336     History of Changes
Other Study ID Numbers: NDX 07-07-0277
07-07-0277
First Submitted: December 20, 2007
First Posted: December 31, 2007
Last Update Posted: June 23, 2015
Last Verified: June 2015

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