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Physician Preference Study of ShuntCheck - Madsen

Primary Purpose

CSF Flow Through the Shunt of a Hydrocephalus Patient

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ShuntCheck

About this trial

This is an interventional diagnostic trial for CSF Flow Through the Shunt of a Hydrocephalus Patient

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Children's Hospital BostonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic

Arm Description

Outcomes

Primary Outcome Measures

ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested

Secondary Outcome Measures

ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction

Full Information

NCT ID

NCT00583336

First Posted

December 20, 2007

Last Updated

June 22, 2015

Sponsor

NeuroDx Development

Collaborators

Boston Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00583336

Brief Title

Physician Preference Study of ShuntCheck - Madsen

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NeuroDx Development

Collaborators

Boston Children's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CSF Flow Through the Shunt of a Hydrocephalus Patient

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

ShuntCheck

Intervention Description

Thermal dilution test for CSF flow

Primary Outcome Measure Information:

Title

ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested

Time Frame

Tested in single visit

Secondary Outcome Measure Information:

Title

ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction

Time Frame

Single visit

10. Eligibility

Sex

All

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle. Subjects must be physically stable as determined by the physician. Exclusion Criteria: Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data. Subjects unable to lie supine with head elevated 30 degrees or less Subjects who have had shunt surgery within two weeks. Inability or unwillingness of subject to endure the test. Other judgments of the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph R Madsen, MD

Phone

(617) 355-6005

Joseph.Madsen@childrens.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph R Madsen, MD

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph R Madsen, MD

12. IPD Sharing Statement

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Physician Preference Study of ShuntCheck - Madsen

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