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Wireless device to check shunt flow in people with hydrocephalus and headaches

Tests a wireless shunt flow device in people with hydrocephalus.

Key facts

Who runs it
Rhaeos, Inc.
Where
Chicago, United StatesSee the site
Trial code
Registry title
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
Status
Recruiting
People taking part
29 people, planned
Started
2 May 2025
Planned end
Dec 2025
Type of study
Interventional
Treatments tested
  • wireless thermal anisotropy measurement device
Record updated
30 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with a shunt that drains brain fluid (CSF) into the belly, who have frequent ongoing headaches. They will test a wireless device on the skin that measures shunt flow.

Age
6 to 80 years
Sex
All sexes
Disease stage
Hydrocephalus with an existing ventriculoperitoneal CSF shunt. Headaches on at least 15 days per month for the past 3 months.
Earlier treatment
Must already have a ventriculoperitoneal shunt. The shunt must be felt under intact skin where it crosses the collarbone.

Main reasons for not taking part

  • More than one shunt tube in the area where the device goes
  • Shunt cannot be felt, or lies deeper than 4 mm on ultrasound
  • Open wound or swelling in the device area
  • History of serious skin reactions to silicone-based adhesives
  • Taking part in another study that may affect the data

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Existing ventriculoperitoneal CSF shunt
  • Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
  • Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
  • Available for remote and in-person follow-up during the 30-day measurement period
  • Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
  • Subject is at least 6 years old but not more than 80 years old

Who cannot take part

  • Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
  • Prior enrollment in this study
  • Subject-reported history of serious adverse skin reactions to silicone-based adhesives
  • Presence of more than one distal shunt catheter in the study device measurement region
  • Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
  • Presence of an interfering open wound or edema in the study device measurement region
  • Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
  • Investigator judges that the subject is unlikely to successfully take reliable measurements at home
  • Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 80 years old?

Where in United States

  • Rhaeos Inc.Chicago, United StatesContact: Anna SomeraTaking people

About the trial

What the trial wants to find out

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.

The group in the trial

  • CSF Shunted Patients with Chronic HeadachesTreatment being tested

    hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

    Treatment: wireless thermal anisotropy measurement device

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
Plain-language title
Wireless device to check shunt flow in people with hydrocephalus and headachesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06996600, who can take part
Record updated
30 May 2025