Recruiting

Observational Study

Sponsor:

Rhaeos, Inc.

Code:

NCT06996600

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 6 - 70+

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 headache and non-headache periods.

Conditions

Hydrocephalus

Study ID

NCT06996600

Start date

May 2, 2025

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Existing ventriculoperitoneal CSF shunt
2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
3. 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
4. Available for remote and in-person follow-up during the 30-day measurement period
5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
7. Subject is at least 6 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of more than one distal shunt catheter in the study device measurement region
2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
7. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
8. 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
9. Prior enrollment in this study
10. 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

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: CSF Shunted Patients with Chronic Headaches

hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

Interventions

wireless thermal anisotropy measurement device

Wireless wearable thermal anisotropy measurement device designed for use at home

Primary outcome measure

  • Correlation Between Study Device Flow Measurement and Subject-reported Headaches [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Rhaeos, Inc

Recruiting

Chicago, Illinois, United States, 60642

Contacts

More Information

Sponsor

Rhaeos, Inc.

Last update posted

May 30, 2025

Last verified

May, 2025

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 2025-05-30.