UnknownNot Applicable

Physician Preference Study of ShuntCheck - Madsen

United States200 participantsStarted 2007-09

Plain-language 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)

Who can participate

Age range85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Tested in single visit

Trial details

NCT IDNCT00583336

SponsorNeuroDx Development

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Contact for this trial

Joseph R Madsen, MD

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

View on ClinicalTrials.gov More CSF Flow Through the Shunt of a Hydrocephalus Patient trials