Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

Hydrocephalus Clinical Trial

Official title:

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410885
• Other study ID #: 2023-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Rhaeos, Inc.
• Contact: Anna Lisa Somera
• Phone: 855-814-3569
• Email: info[@]rhaeos.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with an existing implanted ventricular CSF shunt will be evaluated with the study device in an outpatient setting to determine the negative predictive value (NPV; Part 1, blinded) and explore changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits (Part 2, unblinded).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt

2. Age = 2 years old

3. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device

4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent

5. Standard of care outpatient visit with neurosurgeon assessment of having "no clinical concern for shunt malfunction"

Exclusion criteria

1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit

2. Presence of more than one distal shunt catheter in the study device measurement region

3. Presence of an interfering open wound or edema in the study device measurement region

4. Subject-reported history of adverse skin reactions to silicone adhesives

5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject

6. Subject not available for seven-day follow-up

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Thermal Anisotropy Measurement Device
The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rhaeos, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study device negative predictive value (NPV)	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.	Up to 7 days
Secondary	Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)	The study device will produce either "flow confirmed" or "flow not confirmed" data in a blinded fashion. Ground truth will be established based on 7-day follow-up an intraoperative observations for any surgery performed per the standard of care.	Up to 7 days