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Learn about our clinical programs:
Formative Usability Study
Formative Usability Assessment of Next-Gen Shunt Flow Assessment Devices
Trial Status
Actively Enrolling
Study Type
Formative Usability, Open-label, Non-significant Risk
Location
Rhaeos Clinic, Chicago
Study Participants
Pediatric and adult patients with an existing CSF shunt
Methodology
Measurements of shunt flow will be performed on participants wearing a FlowSense device for up to 2 hours while performing basic daily tasks. Participants will also provide feedback on these next generation shunt flow monitoring devices.
Cost / Payment
Participants compensated $100 for completing the study
Visit ClinicalTrials.gov for complete trial information.
Home-Use Study
All-Day Flow Measurements in the Hospital or Home
Trial Status
Actively Enrolling
Study Type
Prospective, Open-label, Blinded, Single-Arm, Non-significant Risk
Location
3 US hospitals
Study Participants
Pediatric and adult patients with an existing VP shunt
Methodology
Participants will either use the device in an inpatient setting or bring a new flow sensing device home for a month to generate data during their daily lives. Flow data will yield new information about how shunt flow changes throughout the day.
Cost / Payment
Participants compensated $500 for completing the study
Visit ClinicalTrials.gov for complete trial information.
STEALTH Study
Diagnostic Performance of Shunt Patency Detection
Trial Status
Fully Enrolled
Study Type
Prospective, Open-Label, Single-Arm, Non-Significant Risk
Location
9 US hospitals
Study Participants
Pediatric and adult patients with an existing VP shunt and symptoms of a shunt malfunction
Methodology
Participants are evaluated in the hospital with the study device to assess shunt patency. Results will be compared with standard-of-care work up by blinded physicians.
Endpoints
Diagnostic Performance (Accuracy, Sensitivity, Specificity)
Cost / Payment
No cost or payment to participants
Visit ClinicalTrials.gov for complete trial information.
Watch the short video below for additional information.
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Summative Usability Study
Summative Usability of Flow Assessment Device
Trial Status
Fully Enrolled
Study Type
Summative Usability, Open-label, Non-significant Risk
Location
Rhaeos Clinic, Chicago
Study Participants
Clinicians practising in the US with experience in caring for patients with cerebrospinal fluid shunts
Methodology
Participants will use the device in a simulated use environment to assess usability
Cost / Payment
Participants compensated (variable based on role)
Pilot Study
Initial Diagnostic Performance Assessment of New Flow Sensing Technology
Trial Status
Fully Enrolled
Study Type
Prospective, Open-Label, Single-Arm, Non-Significant Risk
Location
3 US hospitals
Study Participants
Pediatric and adult patients with an existing VP shunt and symptoms of a shunt malfunction
Methodology
Patients were evaluated with the study device in the hospital to assess shunt patency. Results were compared with standard-of-care work up by blinded physicians.
Endpoints
Diagnostic Performance (Accuracy, Sensitivity, Specificity)
Cost / Payment
No cost or payment to participants
Visit ClinicalTrials.gov for complete trial information.
