NCT05546996 EVD Drainage Data and Intracranial Pressure (ICP) Measurements
| NCT ID | NCT05546996 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Hydrocephalus |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-07-11 |
| Primary Completion | 2027-01-30 |
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 24 participants in total. It began in 2023-07-11 with a primary completion date of 2027-01-30.
⚠ 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
Rhaeos, Inc. is initially targeting hydrocephalus, a life threatening condition caused by an abnormal accumulation of cerebrospinal fluid (CSF). Implantable shunts, the gold standard treatment, often fail, leading to multiple trips to the emergency room and repeat surgeries. There is no technology available today that can easily assess CSF flow in shunts wirelessly, bedside, and without capital equipment until now. FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of CSF. Similar in size to a bandage, it is composed of soft, silicone with no hard edges. Data is wirelessly transmitted to a custom designed mobile app. With FlowSense, monitoring of shunt function can occur in clinics, in-patient settings, and emergency departments, thereby reducing unnecessary imaging, hospital length of stay, and readmission costs.
Eligibility Criteria
Inclusion Criteria: * Patients with one or more existing external ventricular drains (EVDs). Exclusion Criteria: * Patients with no external ventricular drains (EVDs).
Contact & Investigator
Samuel McClugage, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT05546996 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 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 NCT05546996 currently recruiting?
Yes, NCT05546996 is actively recruiting participants. Contact the research team at mcclugag@bcm.edu for enrollment information.
Where is the NCT05546996 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05546996 clinical trial?
NCT05546996 is sponsored by Baylor College of Medicine. The principal investigator is Samuel McClugage, MD at Baylor College of Medicine. The trial plans to enroll 24 participants.