Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device

This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Neurons Neurosurgical Institute

Cedar Knolls, New Jersey, 07927, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Existing ventricular cerebrospinal fluid shunt
Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
Subject available for 2 week follow-up
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 (Cohort A only)

Exclusion criteria

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 serious adverse skin reactions to silicone-based adhesives
Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject

Treatment and study plan

wireless wearable thermal anisotropy measurement device

Device

non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting

Primary outcomes

Quality of Life

Time frame: 14 days

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. A PROMIS T-score of 50 represents the general population norm, and each 10-point deviation represents one standard deviation from the norm. Higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function).

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Official study title

Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device During Routine Outpatient Surveillance Visits

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 31, 2024
Registry last updated: Feb 10, 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.

Published trials that share one or more normalized conditions with this study.

Completed