NCT06086561

Brief Summary

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 17, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 28, 2023

Last Update Submit

May 12, 2025

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (2)

  • Skin Temperature

    Exploratory assessment of thermal skin measurements taken with the study device

    up to 90 days

  • Acceleration

    Exploratory assessment of accelerometer measurements taken with the study device

    up to 90 days

Study Arms (1)

Feasibility Assessment Cohort

EXPERIMENTAL

Non-invasive device data acquisition; study is not interventional

Device: Thermal Anisotropy Measurement Device

Interventions

Thermal Anisotropy Measurement DeviceDEVICE

The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Feasibility Assessment Cohort

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least one existing ventricular CSF shunt (functional or non-functional, including "virtual off" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)
  • Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
  • Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)
  • Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)
  • Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
  • Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision
  • Patient is at least 5 years old but not more than 80 years old

You may not qualify if:

  • Presence of an interfering open wound or edema over any portion of the shunt
  • Patient-reported history of adverse skin reactions to adhesives
  • Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
  • Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)
  • Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
  • Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
  • Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Tampa Marriott Water Street

Tampa, Florida, 33602, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

WITHDRAWN

MATTER

Chicago, Illinois, 60611, United States

RECRUITING

Northwest Special Recreation Association

Rolling Meadows, Illinois, 60008, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Anna Somera

CONTACT

855-814-3569info@rhaeos.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

October 17, 2023

Study Start

November 17, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)