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Completed

NCT Number: NCT06524492

Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampa Marriott Water Street, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A ventricular CSF shunt with a region of overlying intact skin 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)
  • Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

  • Presence of an interfering open wound or edema in the study device measurement area
  • Patient-reported history of serious adverse skin reactions to silicone-based adhesives
  • Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
  • Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Treatment and study plan

FlowSense

Device

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Primary outcomes

  1. Study Device Sensitivity

    Time frame: Approximately 1 hour

    Study device sensitivity will be calculated as TP / (TP + FN).

  2. Study Device Specificity

    Time frame: Approximately 1 hour

    Study device specificity will be calculated as TN / (TN + FP)

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Official study title

Measurements of Flow in Functional Cerebrospinal Fluid Shunts and Off-Shunt Locations with a Second-Generation Wireless Thermal Anisotropy Measurement Device

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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