Clinical trial NCT05432986: Assessment of CSF Shunt Flow With Thermal Measurements B
Official title: Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 141
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: hydrocephalus patients with an existing ventriculoperitoneal shunt and shunt malfunction symptoms

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Device Sensitivity
timeFrame: 7-day follow-up period
measure: Study Device Specificity
timeFrame: 7-day follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
Study officials:
affiliation: Lurie Children's Hospital
name: Sandi Lam, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: