Flow Detection in Open and Closed Shunt Valve Periods
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does
| Condition(s) | Hydrocephalus |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow. The study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care. This study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt m |
| Who can participate | 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 |
| Sex | All |
| Lead sponsor | Rhaeos, Inc. |
| Locations | Peoria, Illinois, United States |
| Start date | 2026-01-27 |
| NCT ID | NCT07478926 |
| Official listing | https://clinicaltrials.gov/study/NCT07478926 |