Assessment of CSF Shunt Flow With Thermal Measurements B (STEALTH)

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: Thermal Anisotropy Measurement Device

Detailed Description

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital
    • San Francisco, California, United States, 94158
      • UCSF Benioff Children's Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Dayton, Ohio, United States, 45404
      • Dayton Children's Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms

Description

Inclusion criteria

1. Existing ventriculoperitoneal CSF shunt on which the patient 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. Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
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 patient 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)
7. Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

Exclusion criteria

1. Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction
2. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
3. Presence of an interfering open wound or edema over any portion of the shunt
4. Patient-reported history of adverse skin reactions to adhesives
5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
6. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
7. Prior enrollment in this study (multiple main study enrollments of the same patient are disallowed)
8. 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
Hydrocephalus Patients; Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.	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
Study Device Sensitivity	Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.	7-day follow-up period
Study Device Specificity	Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.	7-day follow-up period

Collaborators and Investigators

• Sponsor: Rhaeos, Inc.
• Investigators: Principal Investigator: Sandi Lam, MD, MBA, Lurie Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): November 10, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

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: 2021-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No