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NCT05546996 · ClinicalTrials.gov registry record · NA
EVD Drainage Data and Intracranial Pressure (ICP) Measurements
A NA study of Hydrocephalus, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05546996: Recruiting NA study of Hydrocephalus, sponsored by Baylor College of Medicine.
NCT05546996 is a NA study of Hydrocephalus that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 24 participants, below the 132-participant average among 17 other Hydrocephalus trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05546996, a NA study of Hydrocephalus, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number of participants with accurate cerebrospinal flow rate measurements (measured through the FlowSense device), EVD drainage, intracranial pressure measurements. This will be measured using a video camera. We will see the changes in flow for every 20 minutes in the recording. However, this project is not intended to be statistically powered
Conditions Studied
Interventions
- DEVICE FlowSense
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-07-11 |
| Est. Completion | 2026-01-30 |
| Phase | NA |
What NCT05546996 shows while recruiting
NCT05546996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 132-participant average among 17 other Hydrocephalus trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Hydrocephalus appearing as the primary indexed condition, and to 1 intervention - of which FlowSense is the first listed.
NCT05546996 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05546996 about?
NCT05546996 is a clinical study titled "EVD Drainage Data and Intracranial Pressure (ICP) Measurements". 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 a...
What is the current status of trial NCT05546996?
This trial is currently recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2023-07-11. Estimated completion is 2026-01-30.
What conditions does trial NCT05546996 study?
This clinical trial studies the following conditions: Hydrocephalus.
What interventions are being tested in trial NCT05546996?
The interventions under investigation include: FlowSense (DEVICE).
Who is sponsoring clinical trial NCT05546996?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05546996 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hydrocephalus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05546996's enrollment target sits among peer trials
24 17th of 17 the lowest of 17 other Hydrocephalus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hydrocephalus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
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Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
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MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics
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-
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
ACTIVE NOT RECRUITING · NA
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