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Recruiting NCT07050628

Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

No phase Interventional Hydrocephalus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: wireless thermal anisotropy measurement device.
Who it may be relevant to
Registry conditions: Hydrocephalus. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep

Overview

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 activities of daily living and sleep

Interventions

  • Device wireless thermal anisotropy measurement device
    Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms

Primary outcome measures

  • Adverse Device Effects [Time frame: 30 days]
Secondary outcome measures (6)
  • ADEs and SADEs per wear period [Time frame: 30 days]
  • ADEs and SADEs per subject [Time frame: 30 days]
  • ADEs and SADEs that preclude the continued use of the study device [Time frame: 30 days]
  • Device deficiencies resulting in incomplete monitoring data [Time frame: 30 days]
  • Local skin reactions per wear session; [Time frame: 30 days]
  • Usability score [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Existing ventricular CSF shunt
  • (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
  • (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
  • 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
  • Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Subject is at least 5 years old but < 22 years old

Exclusion criteria

  • Shunt is not palpable 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 2 centers
  • Rhaeos Inc. — Chicago
  • Virginia Commonwealth University Medical Center — Richmond

Identifiers

NCT: NCT07050628 · 2025-03 · 5UG3NS130338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗