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CompletedNCT06753929Updated Feb 10, 2025

Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device

An interventional study of wireless wearable thermal anisotropy measurement device in Hydrocephalus, sponsored by Rhaeos, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Rhaeos, Inc. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Feb 2025, 1 year 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study summary

This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.

02

Conditions studied

  • Hydrocephalus

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03

In context

Hydrocephalus

210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 105 interventional studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

Rhaeos, Inc. is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Existing ventricular cerebrospinal fluid shunt
  2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
  3. Subject available for 2 week follow-up
  4. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)

Exclusion criteria

Exclusion Criteria

  1. Presence of more than one distal shunt catheter in the study device measurement region
  2. Presence of an interfering open wound or edema in the study device measurement region
  3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
  4. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    CSF Shunted Patients

    The trial will include two cohorts. The study device will be used to assess CSF flow in Cohort A (prospective). The study device will not be used for Cohort B (retrospective).

    Device: wireless wearable thermal anisotropy measurement device

Interventions

  • Devicewireless wearable thermal anisotropy measurement device

    non-invasive device used for assessing CSF shunt flow via thermal anisotropy measurements in a routine outpatient clinic setting

06

What researchers measure

Primary outcomes

  1. Quality of Life

    Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. A PROMIS T-score of 50 represents the general population norm, and each 10-point deviation represents one standard deviation from the norm. Higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function).

    Time frame: 14 days

07

Study locations

1 site
  • New Neurons Neurosurgical Institute
    Cedar Knolls, New Jersey 07927, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06753929
Lead sponsor
Rhaeos, Inc.
Responsible party
Sponsor
First posted
Dec 31, 2024
Start date
Dec 10, 2024
Primary completion
Feb 5, 2025
Completion
Feb 5, 2025
Last update
Feb 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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