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Recruiting NCT06086561

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy 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: Thermal Anisotropy Measurement Device.
Who it may be relevant to
Registry conditions: Hydrocephalus. Basic parameters: 5 years — 80 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 →

Overview

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Interventions

  • Device Thermal Anisotropy Measurement Device
    The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Primary outcome measures

  • Skin Temperature [Time frame: up to 90 days]
  • Acceleration [Time frame: up to 90 days]

Eligibility criteria

Inclusion criteria

  • At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
  • Region(s) of intact skin overlying at least one unambiguously identifiable 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 (for subjects using the study device at home)
  • Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
  • 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
  • Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
  • Patient is at least 5 years old but not more than 80 years old

Exclusion criteria

  • Presence of an interfering open wound or edema over any portion of the shunt
  • Patient-reported history of adverse skin reactions to 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 (for subjects using the study device 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
  • 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
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 4 centers
  • Tampa Marriott Water Street — Tampa
  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
  • MATTER — Chicago
  • Northwest Special Recreation Association — Rolling Meadows

Identifiers

NCT: NCT06086561 · 2023-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗