Physician Preference Study of ShuntCheck - Madsen

CSF Flow Through the Shunt of a Hydrocephalus Patient Clinical Trial

Official title:

Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00583336
• Other study ID #: NDX 07-07-0277
• Secondary ID: 07-07-0277
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2007
• Last updated: June 22, 2015
• Start date: September 2007
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: NeuroDx Development
• Contact: Joseph R Madsen, MD
• Phone: (617) 355-6005
• Email: Joseph.Madsen[@]childrens.harvard.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• CSF Flow Through the Shunt of a Hydrocephalus Patient
• Hydrocephalus

Intervention

Device:
• ShuntCheck
Thermal dilution test for CSF flow

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NeuroDx Development	Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested		Tested in single visit	No
Secondary	ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction		Single visit	No