Checking how easy a wireless shunt flow sensor is to use in hydrocephalus
Looks at how people use a wireless sensor measuring brain fluid shunt flow.
Key facts
- Who runs it
- Rhaeos, Inc.
- Where
- Chicago, United StatesSee the site
- Trial code
- Registry title
- Formative Usability Assessment of Wireless Thermal Anisotropy Devices
- Status
- Recruiting
- People taking part
- 145 people, planned
- Started
- 29 Sept 2023
- Planned end
- Dec 2025
- Type of study
- Observational
- Treatments tested
- Thermal Anisotropy
- Record updated
- 15 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 aged 5 to 80 who already have a shunt draining brain fluid (CSF shunt). It tests how easy a wireless skin device that measures shunt flow is to use.
- Age
- 5 to 80 years
- Sex
- All sexes
- Disease stage
- People with an existing ventricular CSF shunt, with intact skin over the shunt tube large enough for the device.
- Earlier treatment
- Must already have a ventricular CSF shunt in place.
Main reasons for not taking part
- An open wound where the device would be placed
- History of skin reactions to adhesives
- Neither the person nor a caregiver can communicate and write information in English
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
- Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- Subject or caregiver can clearly communicate and document information in English
- Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
- Subject is at least 5 years old but not more than 80 years old
Who cannot take part
- Subject-reported history of adverse skin reactions to adhesives
- Presence of an interfering open wound in the device application region
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 5 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
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
The group in the trial
- Usability Assessment Cohort
No interventions administered. Device usability assessment only.
Treatment: Thermal Anisotropy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts
- Plain-language title
- Checking how easy a wireless shunt flow sensor is to use in hydrocephalusGenerated 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 NCT06040697, who can take part
- Record updated
- 15 May 2025