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FlowSense Monitoring for Hydrocephalus (RHAEOS Trial)

N/A

Recruiting

Led By Samuel McClugage, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

RHAEOS Trial Summary

This trial tech aims to improve care for those suffering from hydrocephalus, providing a wireless, noninvasive way to monitor CSF flow in shunts and reduce unnecessary imaging, hospital stays & readmissions.

Who is the study for?

This trial is for patients who have hydrocephalus and currently have one or more external ventricular drains (EVDs) in place. It's not suitable for those without any EVDs.Check my eligibility

What is being tested?

The trial is testing FlowSense, a wireless, noninvasive device that monitors cerebrospinal fluid flow through shunts to detect blockages or malfunctions without the need for complex equipment.See study design

What are the potential side effects?

Since FlowSense is noninvasive and similar to wearing a bandage on the neck, it likely has minimal side effects related to skin contact such as potential irritation or discomfort at the site of application.

RHAEOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Exploratory outcome

Secondary outcome measures

Suitability

RHAEOS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase BExperimental Treatment1 Intervention

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements (FlowSense Flow Rate) and: A) EVD drainage data, quantified via video recording; B) intracranial pressure (ICP) measurements

Group II: Phase A:Active Control1 Intervention

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rhaeos, Inc.Industry Sponsor

4 Previous Clinical Trials

359 Total Patients Enrolled

4 Trials studying Hydrocephalus

359 Patients Enrolled for Hydrocephalus

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,388 Total Patients Enrolled

2 Trials studying Hydrocephalus

624 Patients Enrolled for Hydrocephalus

Samuel McClugage, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Phase B Clinical Trial Eligibility Overview. Trial Name: NCT05546996 — N/A

Hydrocephalus Research Study Groups: Phase B, Phase A:

Hydrocephalus Clinical Trial 2023: Phase B Highlights & Side Effects. Trial Name: NCT05546996 — N/A

Phase B 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546996 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial still open?

"Data on clinicaltrials.gov shows that this research is actively recruiting subjects. It was first posted on July 11th, 2023 and last updated 14 days later."

Answered by AI

Is the age range for this research project inclusive of individuals aged 55 or greater?

"According to the study's entry requirements, only individuals 1 year and older up to 21 years are eligible. Furthermore, there are 5 medical trials catered specifically for minors (below 18) and a total of 18 clinical studies open for seniors over 65."

Answered by AI

Is it feasible to enroll in this research trial?

"This experiment is seeking 24 minors between 1 and 21 years old who possess hydrocephalus in addition to an existing external ventricular drain (EVD)."

Answered by AI

How many volunteers are taking part in this experiment?

"Affirmative. As indicated by the information on clinicaltrials.gov, this trail is currently enrolling participants since July 11th 2023 and was last updated 14 days later. 24 people are required to take part in the trial at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EVD Drainage Data and Intracranial Pressure (ICP) Measurements

Samuel McClugage 2023. "EVD Drainage Data and Intracranial Pressure (ICP) Measurements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546996.

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