Wearable sensor to detect CSF flow in shunt tubing
Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods
This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Sex | All |
| Sponsor | Rhaeos, Inc. Industry-sponsored |
| Locations | 1 site (Peoria, Illinois) |
| Trial ID | NCT07478926 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter, open-label but blinded observational study tests a noninvasive wireless thermal flow detection device placed on the skin over ventricular shunt tubing. The device applies gentle, controlled warmth and measures temperature patterns that differ when CSF is flowing versus not flowing, with data captured via a tablet app and encoded to preserve blinding. All participants have at least one measurement with their valve at its usual flow-permissive setting, and a subset with programmable valves also undergo a temporary 'virtual off' measurement before the valve is returned to its prior setting. The device does not penetrate the skin and does not change clinical care during the measurement process.
Who should consider this trial
Good fit: Children and adults who already have an implanted ventricular CSF shunt, have intact skin over a palpable shunt crossing the clavicle, and do not have new or worsening symptoms of shunt malfunction are ideal candidates.
Not a fit: Patients with suspected acute shunt malfunction, wounds or scarring over the shunt site, non-palpable or atypically routed shunt tubing, or who cannot undergo temporary valve programming adjustments are less likely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could provide a quick, noninvasive way to determine whether a shunt is flowing and reduce reliance on invasive tests or indirect imaging.
How similar studies have performed: Thermal, wearable flow-detection for CSF shunts is relatively novel, with only limited pilot data reported to date rather than large, established trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria * Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively * 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 or legal guardian, health care agent, or surrogate decision maker (according to local statutes) * Subject-reported or documented history of successful valve adjustment(s) Inclusion and Exclusion Criteria for Main Study Subjects Inclusion criteria * Existing ventricular CSF shunt * 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) Subjects with planned "virtual off" measurement: -Existing ventricular CSF shunt with an available "virtual off" setting which can be programmed noninvasively Subjects with planned adjustment to the "virtual off" setting only: -Subject-reported or documented history of successful valve adjustment(s) Exclusion Criteria: Exclusion criteria * Presence of more than one distal shunt catheter in the study device measurement region * Presence of an interfering open wound or edema in the study device measurement region * Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement * Shunt valve is set to an opening pressure of \>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt) * Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus) * Subject has more than one intact and presumed functional distal catheter * Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives * Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days * 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 Exclusion Criteria for Main Study Subjects Exclusion criteria * Presence of more than one distal shunt catheter in the study device measurement region * Presence of an interfering open wound or edema in the study device measurement region * Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement * Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives * Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days * 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 * Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data Subjects with planned "valve normal" measurements: * Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt) * Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus) * Subject has more than one intact and presumed functional distal catheter
Where this trial is running
Peoria, Illinois
- OSF Healthcare — Peoria, 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.