Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device

NCT06524492 | Completed FDA Device

• 1 other identifier: 2024-04
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 3

Brief Summary

This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations 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).

  Approximately 1 hour

• Study Device Specificity

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

  Approximately 1 hour

Study Arms (1)

FlowSense

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

Device: FlowSense

Interventions

FlowSense DEVICE

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

FlowSense

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:

• A ventricular CSF shunt with a region of overlying intact skin appropriate in size for application of the study device
• 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 study device measurement area
• Patient-reported history of serious adverse skin reactions to silicone-based adhesives
• Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
• Patient or caregiver report of new or worsening symptoms of a possible shunt malfunction in the prior 7 days
• 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 (3)

Tampa Marriott Water Street

Tampa, Florida, 33602, United States

Location

Rhaeos, Inc.

Chicago, Illinois, 60654, United States

Location

Northwest Special Recreation Association

Rolling Meadows, Illinois, 60008, 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 23, 2024
• First Posted: July 29, 2024
• Study Start: July 25, 2024
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)