Clinical trial NCT06506045: Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device
Official title: Measurements of Flow in Functional and Non-Functional Cerebrospinal Fluid Shunts With a Second-Generation Wireless Thermal Anisotropy Measurement Device
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-17
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: Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.

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


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 adverse skin reactions to adhesives
3. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired
4. New or worsening symptoms of a possible shunt malfunction in the prior 7 days
5. 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
6. 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: Study Device Sensitivity
timeFrame: Up to 1 hour
measure: Study Device Specificity
timeFrame: Up to 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: