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 range

85 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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