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Not yet recruiting NCT06410885

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

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: 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 →

Overview

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).

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

  • Study device negative predictive value (NPV) [Time frame: Up to 7 days]
Secondary outcome measures (1)
  • Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV) [Time frame: Up to 7 days]

Eligibility criteria

Inclusion criteria

  • Existing ventricular cerebrospinal fluid shunt
  • Age ≥ 2 years old
  • Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device
  • Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent
  • Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

Exclusion criteria

  • Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit
  • Presence of more than one distal shunt catheter in the study device measurement region
  • Presence of an interfering open wound or edema in the study device measurement region
  • Subject-reported history of adverse skin reactions to silicone adhesives
  • Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
  • Subject not available for seven-day follow-up

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
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • UCSF Benioff Children's Hospital — San Francisco

Identifiers

NCT: NCT06410885 · 2023-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗