Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices

NCT06513572 | Terminated FDA Device

• 1 other identifier: 2024-03
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 8

Brief Summary

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• Correlation of measurement data

  Correlation between measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

  Approximately 1 hour

Interventions

FlowSense DEVICE

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.

Eligibility Criteria

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

Study Population

Individuals with at least one existing CSF shunt

You may qualify if:

• At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
• If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

You may not qualify if:

• Presence of an interfering open wound or edema in the FlowSense device measurement area
• Patient-reported history of serious adverse skin reactions to silicone-based adhesives
• Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
• Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (8)

CHOC Commerce Tower

Orange, California, 92868, United States

Location

Cedars-Sinai Accelerator

West Hollywood, California, 90048, United States

Location

Tampa Marriott Water Street

Tampa, Florida, 33602, United States

Location

MATTER

Chicago, Illinois, 60611, United States

Location

Industrious

Evanston, Illinois, 60201, United States

Location

Northwest Special Recreation Association

Rolling Meadows, Illinois, 60008, United States

Location

Texas Medical Center Innovation

Houston, Texas, 77021, United States

Location

Industrious

Seattle, Washington, 98015, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 25, 2024
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (8)