Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

Официальное название

Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep

Обзор

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep

Вмешательства

• Устройство wireless thermal anisotropy measurement device
  Wireless wearable thermal anisotropy measurement device designed for use at home will be provided to study subjects in both study arms

Первичные конечные точки

• Adverse Device Effects [Срок оценки: 30 days]

Вторичные конечные точки (6)

• ADEs and SADEs per wear period [Срок оценки: 30 days]
• ADEs and SADEs per subject [Срок оценки: 30 days]
• ADEs and SADEs that preclude the continued use of the study device [Срок оценки: 30 days]
• Device deficiencies resulting in incomplete monitoring data [Срок оценки: 30 days]
• Local skin reactions per wear session; [Срок оценки: 30 days]
• Usability score [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Existing ventricular CSF shunt
• (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
• (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
• Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject is at least 5 years old but < 22 years old

Критерии исключения

• Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
• Presence of an interfering open wound or edema in the study device measurement region
• Subject-reported history of serious adverse skin reactions to silicone-based adhesives
• Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• Investigator judges that the subject is unlikely to successfully take reliable measurements at home
• Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
• 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
• Prior enrollment in this study
• Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 2 центра

• Rhaeos Inc. — Chicago
• Virginia Commonwealth University Medical Center — Richmond

Идентификаторы

NCT: NCT07050628 · 2025-03 · 5UG3NS130338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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