Recruiting

Observational Study

Sponsor:

Rhaeos, Inc.

Code:

NCT06086561

Conditions

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

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. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Conditions

Hydrocephalus

Study ID

NCT06086561

Start date

Nov 17, 2023

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
2. Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
3. Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
4. Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
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. Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
8. Patient is at least 5 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of an interfering open wound or edema over any portion of the shunt
2. Patient-reported history of adverse skin reactions to adhesives
3. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
4. Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)
5. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
6. 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
7. 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

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Feasibility Assessment Cohort

Non-invasive device data acquisition; study is not interventional

Interventions

Thermal Anisotropy Measurement Device

The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Primary outcome measure

  • Skin Temperature [ Time Frame: up to 90 days ]
  • Acceleration [ Time Frame: up to 90 days ]

Central Contacts and Locations

Central contacts

Locations

Tampa Marriott Water Street

Recruiting

Tampa, Florida, United States, 33602

Contacts

MATTER

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Northwest Special Recreation Association

Recruiting

Rolling Meadows, Illinois, United States, 60008

Contacts

More Information

Sponsor

Rhaeos, Inc.

Last update posted

May 15, 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 2025-05-15.