Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device

This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.

Study Overview

• Status: Not yet recruiting
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: Thermal Anisotropy Measurement Device

• Study Type: Observational
• Enrollment (Estimated): 17

Contacts and Locations

• Study Contact: Name: Anna Lisa Somera; Phone Number: 855-814-3569; Email: info@rhaeos.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult shunt-dependent hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation without use of the study device data will be enrolled in this study.

Description

Inclusion Criteria:

1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent
2. At least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function
3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data
4. Region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
5. Available for follow-up for up to seven days
6. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol)

Exclusion Criteria:

1. Presence of more than one distal shunt catheter in the study device measurement region
2. Presence of an interfering open wound or edema in the study device measurement area
3. Subject-reported history of adverse skin reactions to adhesives
4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
7. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shunted patients undergoing surgery; Patients with an existing implanted ventriculoperitoneal shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation	Device: Thermal Anisotropy Measurement Device; A wireless device for non-invasively assessing CSF shunt flow; Other Names: FlowSense

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flowsense Sensitivity	The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed True Negative (TN): Device outputs "flow confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed False Negative (FN): Device outputs "flow confirmed" AND a shunt revision surgery with confirmed shunt failure is performed Study device sensitivity will be calculated as TP / (TP + FN).	Upto 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study device specificity, diagnostic accuracy, positive predictive value (PPV), negative predictive value (NPV), and diagnostic performance	These secondary endpoints do not have associated success criteria. The study is not powered to achieve statistical significance for these endpoints.	Up to 7 days

Collaborators and Investigators

• Sponsor: Rhaeos, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: 2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes