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

Rhaeos, Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hydrocephalus

Interventions

wireless wearable thermal anisotropy measurement deviceDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

New Neurons Neurosurgical Institute

Cedar Knolls, New Jersey, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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