Physician Preference Study of ShuntCheck - Madsen

NeuroDx Development200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

CSF Flow Through the Shunt of a Hydrocephalus Patient

Interventions

ShuntCheckDEVICE

Thermal dilution test for CSF flow

Eligibility

Sex: ALLMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital Boston

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Tested in single visit

Secondary Outcomes

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

Time frame: Single visit

Central Contacts

Joseph R Madsen, MD

CONTACT

(617) 355-6005 Joseph.Madsen@childrens.harvard.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.