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

Not Applicable

Completed

• Conditions: Hydrocephalus

• Registration Number: NCT06753929
• Lead Sponsor: Rhaeos, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-09
• Study Start: 2024-12-10
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2024-12-31
• Status Verified: 2025-02
• Primary Completion: 2025-02-05
• Study Completion: 2025-02-05
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

New Neurons Neurosurgical Institute; 🇺🇸 Cedar Knolls, New Jersey, United States