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

NCT07050628 | Not Yet Recruiting FDA Device

• 2 other identifiers: 2025-035UG3NS130338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Adverse Device Effects

  The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour.

  30 days

Secondary Outcomes (6)

• ADEs and SADEs per wear period

  30 days

• ADEs and SADEs per subject

  30 days

• ADEs and SADEs that preclude the continued use of the study device

  30 days

• Device deficiencies resulting in incomplete monitoring data

  30 days

• Local skin reactions per wear session;

  30 days

Study Arms (2)

No Recent Revision

EXPERIMENTAL

Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.

Device: wireless thermal anisotropy measurement device

Recent Revision

EXPERIMENTAL

Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.

Device: wireless thermal anisotropy measurement device

Interventions

wireless thermal anisotropy measurement device DEVICE

Wireless wearable thermal anisotropy measurement device designed for use at home

No Recent Revision; Recent Revision

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhaeos, Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Rhaeos Inc.

Chicago, Illinois, 60642, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna Somera

CONTACT

855-814-3569; clinical@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)