Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device

NCT06506045 | Terminated FDA Device

• 1 other identifier: 2024-02
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 8

Brief Summary

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (2)

• Study Device Sensitivity

  Study device sensitivity will be calculated as TP / (TP + FN).

  Up to 1 hour

• Study Device Specificity

  Study device specificity will be calculated as TN / (TN + FP)

  Up to 1 hour

Interventions

FlowSense DEVICE

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.

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

Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.

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 adverse skin reactions to adhesives
• Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
• New or worsening symptoms of a possible shunt malfunction in the prior 7 days
• 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 11, 2024
• First Posted: July 17, 2024
• Study Start: July 27, 2024
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (8)