Physician Preference Study of ShuntCheck - Madsen

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

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)

Study Overview

• Status: Unknown
• Conditions: CSF Flow Through the Shunt of a Hydrocephalus Patient
• Intervention / Treatment: Device: ShuntCheck

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph R Madsen, MD; Phone Number: (617) 355-6005; Email: Joseph.Madsen@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Children's Hospital Boston
      • Principal Investigator: Joseph R Madsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic	Device: ShuntCheck; Thermal dilution test for CSF flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested	Tested in single visit

Secondary Outcome Measures

Outcome Measure	Time Frame
ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction	Single visit

Collaborators and Investigators

• Sponsor: NeuroDx Development
• Collaborators: Boston Children's Hospital
• Investigators: Principal Investigator: Joseph R Madsen, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): December 31, 2007

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: NDX 07-07-0277; 07-07-0277