TerminatedNot Applicable

Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

Stopped: Enrollment

United States10 participantsStarted 2024-07-25

Plain-language summary

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Who can participate

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

. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

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

Correlation of measurement data

Timeframe: Approximately 1 hour

Trial details

NCT IDNCT06513572

SponsorRhaeos, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-27

View on ClinicalTrials.gov More Hydrocephalus trials

Who can participate

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

. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision