Recruiting

Observational Study

Sponsor:

Rhaeos, Inc.

Code:

NCT07050628

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

wireless thermal anisotropy measurement device

Study Details

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

Study ID

NCT07050628

Start date

Nov 10, 2025

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Existing ventricular CSF shunt
2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
3. (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
4. 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
5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
6. Subject is at least 5 years old but < 22 years old

Exclusion Criteria:

1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
2. Presence of an interfering open wound or edema in the study device measurement region
3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
6. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
7. 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
8. Prior enrollment in this study
9. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Study Design

Enrollment

28 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: No Recent Revision

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.

experimental: Recent Revision

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.

Interventions

wireless thermal anisotropy measurement device

Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms

Primary outcome measure

  • Adverse Device Effects [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Rhaeos Inc.

Recruiting

Chicago, Illinois, United States, 60642

Contacts

Virginia Commonwealth University Medical Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

More Information

Sponsor

Rhaeos, Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rhaeos, Inc. on 2026-08-25.