Clinical
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 $50 for completing the study
Visit ClinicalTrials.gov for complete trial information.
Home-Use Study (Puerto Rico)
Mediciones de flujo durante todo el día en el hospital o en el hogar
Estado del Estudio
Inscripción Activa
Tipo de Estudio
Prospectivo, Abierto, Ciego, de un Solo Grupo, Riesgo No Significativo
Ubicación
San Juan, Puerto Rico
Participantes del Estudio
Pacientes pediátricos y adultos con una derivación de LCR existente
Metodología
Los participantes utilizarán el dispositivo durante un mes para recopilar datos en el transcurso de su vida diaria. Los datos del flujo proporcionarán nueva información sobre cómo cambia el flujo de la derivación a lo largo del día.
Costo / Compensación
Los participantes recibirán $500 USD al completar el estudio
Formulario del Estudio Clínico
Visite ClinicalTrials.gov para obtener información completa sobre el estudio.
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 (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.
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.
