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

Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device During Routine Outpatient Surveillance Visits

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06753929

Enrollment

Registered

2024-12-31

Start date

2024-12-10

Completion date

2025-02-05

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Brief 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.

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	14 days	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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026