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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

Study 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.Check my eligibility

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.See study design

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

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I have a clear skin area over my long-term ventricular shunt near my collarbone for the study device.

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I or my caregiver can communicate and document symptoms in English clearly.

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I am between 6 and 80 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

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

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

Primary outcome measures

Acceleration

Skin Temperature

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhaeos, Inc.Lead Sponsor

4 Previous Clinical Trials

353 Total Patients Enrolled

4 Trials studying Hydrocephalus

353 Patients Enrolled for Hydrocephalus

Frequently Asked Questions

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

What is the current size of this experimental cohort?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was inaugurated on November 17th 2023, is currently recruiting volunteers for participation. 30 people are required from a single location."

Answered by AI

Is there still capacity for additional participants in this clinical trial?

"Per information on clinicaltrials.gov, this trial is actively enrolling participants and was last updated on November 17th, 2023 - the same day it was first published."

Answered by AI

Does this research involve individuals over the age of thirty?

"This trial's eligibility criteria calls for participants aged 6 to 80. There are also additional trials available specifically tailored towards those under 18 and over 65, totalling 31 studies in all."

Answered by AI

Are the criteria I meet sufficient for me to join this medical experiment?

"To be accepted to this trial, potential participants must have been diagnosed with hydrocephalus and must fall in the age range of 6-80. Approximately 30 people will partake in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device

2023. "Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06086561.

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