NCT06040697

Brief Summary

Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
2.2 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

2.2 years

First QC Date

August 31, 2023

Last Update Submit

May 12, 2025

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

  • Exploratory device usability feedback

    Identification of usability risks \[unscored\]

    2 hours

Study Arms (1)

Usability Assessment Cohort

No interventions administered. Device usability assessment only.

Device: Thermal Anisotropy

Interventions

Thermal AnisotropyDEVICE

Usability assessment observation.

Also known as: FlowSense
Usability Assessment Cohort

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with an existing Cerebrospinal Fluid (CSF) shunt

You may qualify if:

  • Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device
  • Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  • Subject or caregiver can clearly communicate and document information in English
  • Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision
  • Subject is at least 5 years old but not more than 80 years old

You may not qualify if:

  • Presence of an interfering open wound in the device application region
  • Subject-reported history of adverse skin reactions to adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhaeos, Inc.

Chicago, Illinois, 60654, 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
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 15, 2023

Study Start

September 29, 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(1)