Measuring cerebrospinal fluid flow in shunts using a wireless device
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
This study tests a new wireless device that patients with ventricular shunts can wear to see how well their cerebrospinal fluid is flowing over 30 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 5 Years to 80 Years |
| Sex | All |
| Sponsor | Rhaeos, Inc. Industry-sponsored |
| Locations | 4 sites (Tampa, Florida and 3 other locations) |
| Trial ID | NCT06086561 on ClinicalTrials.gov |
What this trial studies
This study evaluates a wireless thermal anisotropy measurement device designed to non-invasively assess the flow of cerebrospinal fluid (CSF) in patients with existing ventricular shunts. Participants will wear the device to collect longitudinal data on CSF flow over a 30-day period, allowing for both remote and in-person follow-up. The goal is to improve the understanding of shunt performance and potentially enhance patient management.
Who should consider this trial
Good fit: Ideal candidates include individuals with at least one existing ventricular CSF shunt, regardless of its functional status.
Not a fit: Patients without an implanted ventricular CSF shunt or those unable to communicate effectively about their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and management of patients with hydrocephalus, improving their quality of life.
How similar studies have performed: While the approach of using a wireless device for monitoring CSF flow is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida and 3 other locations
- Tampa Marriott Water Street — Tampa, Florida, United States (Recruiting)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Withdrawn)
- Matter — Chicago, Illinois, United States (Recruiting)
- Northwest Special Recreation Association — Rolling Meadows, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Anna Somera
- Email: info@rhaeos.com
- Phone: 855-814-3569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.