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Wireless Shunt Flow Measurement Device for Hydrocephalus

N/A
Recruiting
Research Sponsored by Rhaeos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial studies a device to measure CSF flow in patients with implanted shunts. Patients wear it to get long-term data.

Who is the study for?
This trial is for people aged 6-80 with hydrocephalus who have a ventriculoperitoneal CSF shunt and intact skin where the device will be placed. Participants must speak English, provide consent, and be available for follow-ups. Minors over 12 must give verbal assent.
What is being tested?
The study tests a new device that measures cerebrospinal fluid flow in shunts non-invasively. Patients with existing shunts wear the device to collect data over time, both at home and possibly in a hospital setting.
What are the potential side effects?
Since this trial involves wearing a measurement device rather than taking medication or undergoing surgery, side effects are minimal but may include discomfort or skin irritation where the device is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a clear skin area over my long-term ventricular shunt near my collarbone for the study device.
Select...
I or my caregiver can communicate and document symptoms in English clearly.
Select...
I am between 6 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceleration
Skin Temperature

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Feasibility Assessment CohortExperimental Treatment1 Intervention
Non-invasive device data acquisition; study is not interventional
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thermal Anisotropy Measurement Device
2022
N/A
~190

Find a Location

Who is running the clinical trial?

Rhaeos, Inc.Lead Sponsor
9 Previous Clinical Trials
526 Total Patients Enrolled
~26 spots leftby Mar 2025
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