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

NCT06753929 | Completed FDA Device

• 1 other identifier: 2024-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Outcome Measures

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).

  14 days

Study Arms (1)

CSF Shunted Patients

EXPERIMENTAL

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

wireless wearable thermal anisotropy measurement device DEVICE

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

CSF Shunted Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing ventricular cerebrospinal fluid shunt
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject available for 2 week follow-up
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (1)

New Neurons Neurosurgical Institute

Cedar Knolls, New Jersey, 07927, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 31, 2024
• Study Start: December 10, 2024
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)