NCT06996600 Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
| NCT ID | NCT06996600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rhaeos, Inc. |
| Condition | Hydrocephalus |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2025-05-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06996600 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 80 Years, studying Hydrocephalus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996600 currently recruiting?
Yes, NCT06996600 is actively recruiting participants. Contact the research team at clinical@rhaeos.com for enrollment information.
Where is the NCT06996600 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06996600 clinical trial?
NCT06996600 is sponsored by Rhaeos, Inc.. The trial plans to enroll 29 participants.