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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE FlowSense

Study Locations (1)

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-07-11
Est. Completion 2026-01-30
Phase NA

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT05546996

The ClinicalTrials.gov registry entry for NCT05546996 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 17 other Hydrocephalus trials with a reported enrollment target (82% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.