Clinical trial NCT06513572: Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
Official title: Measurements of Cerebrospinal Fluid Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with at least one existing CSF shunt

Brief summary: This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.


Eligibility criteria: Inclusion criteria:

1. 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
2. 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
3. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
5. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria:

1. Presence of an interfering open wound or edema in the FlowSense device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. 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
4. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Primary outcomes:
measure: Correlation of measurement data
timeFrame: Approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC Commerce Tower
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Accelerator
state: California
city: Tampa
country: United States
facility: Tampa Marriott Water Street
state: Florida
city: Chicago
country: United States
facility: MATTER
state: Illinois
city: Evanston
country: United States
facility: Industrious
state: Illinois
city: Rolling Meadows
country: United States
facility: Northwest Special Recreation Association
state: Illinois
city: Houston
country: United States
facility: Texas Medical Center Innovation
state: Texas
city: Seattle
country: United States
facility: Industrious
state: Washington
Study officials:
References: