Recruiting

ShuntCheck

Sponsor:

NeuroDx Development

Code:

NCT00583336

Conditions

CSF Flow Through the Shunt of a Hydrocephalus Patient

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

ShuntCheck

Study Details

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)

Conditions

CSF Flow Through the Shunt of a Hydrocephalus Patient

Study ID

NCT00583336

Start date

Sep, 2007

Status verified date

Jun, 2015

Completion date

Sep, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic

Interventions

ShuntCheck

Thermal dilution test for CSF flow

Primary outcome measure

  • ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested [ Time Frame: Tested in single visit ]

Central Contacts and Locations

Central contacts

Joseph R Madsen, MD

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

Locations

Children's Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Joseph R Madsen, MD

More Information

Sponsor

NeuroDx Development

Last update posted

Jun 23, 2015

Last verified

Jun, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NeuroDx Development on 2015-06-23.