Assessment of CSF Shunt Flow With Thermal Measurements B

NCT05432986 | Completed Results FDA Device

• 1 other identifier: 2021-01
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Hydrocephalus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Hydrocephalus Patients

Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.

Device: Thermal Anisotropy Measurement Device

Interventions

Thermal Anisotropy Measurement Device DEVICE

A wireless device for non-invasively assessing CSF shunt flow.

Also known as: FlowSense

Hydrocephalus Patients

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

hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms

You may qualify if:

• Existing ventriculoperitoneal CSF shunt on which the patient is dependent
• 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
• Suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement
• 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
• Available for follow-up for up to seven days
• 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)
• Verbal assent by minors four years of age and older who are able to understand the study and communicate their decision

You may not qualify if:

• 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
• Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed
• Presence of an interfering open wound or edema over any portion of the shunt
• Patient-reported history of adverse skin reactions to adhesives
• Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject
• Prior enrollment in this study (multiple main study enrollments of the same patient are disallowed)
• 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 (10)

UCSF Benioff Children's Hospital

Oakland, California, 94609, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Anna Somera
• Organization: Rhaeos, Inc.

info@rhaeos.com

855-814-3569

Study Officials

• Sandi Lam, MD, MBA

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: July 7, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 10, 2023
• Last Updated: February 20, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Locations

US (10)