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Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device

Rhaeos, Inc. · NCT06996600

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
29
US sites recruiting
1
Study start
May 2, 2025
Record last updated
May 30, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: wireless thermal anisotropy measurement device

Conditions: Hydrocephalus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Subject-reported history of serious adverse skin reactions to silicone-based adhesives
  • 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
  • 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
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Recruiting US locations

  • Rhaeos, Inc

    Chicago, IL 60642

    Site contact: Anna Somera · 855-814-3569 · clinical@rhaeos.com

Study contacts (from the official record)

  • Anna Somera · 855-814-3569 · clinical@rhaeos.com
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Assessment of CSF Shunt Flow and Headaches With a Thermal… (NCT06996600) | Bored Studies