[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rhaeos, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":202},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,69,91,112,133,150,168,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100645209","study-of-shunt-flow-under-different-valve-settings-using-a-wireless-sensor-100645209",false,"NCT07679035","Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor","A Prospective Study Comparing CSF Shunt Flow Between \"Virtual Off\" and \"Flow-Permissive\" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor","Inclusion Criteria:\n\nExisting ventricular cerebrospinal fluid (CSF) shunt. Region of intact skin overlying an unambiguously identifiable, palpable, chronically indwelling ventricular shunt crossing the clavicle and appropriate in size for application of the study device.\n\nWritten informed consent provided by the participant or, when applicable, by a parent, legal guardian, health care agent, or surrogate decision maker according to local regulations.\n\nFor participants with planned \"virtual off\" measurements:\n\nExisting ventricular CSF shunt with a programmable valve that has an available manufacturer-reported \"virtual off\" setting and can be programmed noninvasively.\n\nFor participants whose valve will be adjusted to the \"virtual off\" setting during the study:\n\nSubject-reported or documented history of successful shunt valve adjustment(s).\n\nExclusion Criteria:\n\nPresence of more than one distal shunt catheter in the study device measurement region.\n\nPresence of an open wound or edema in the study device measurement region that would interfere with device placement.\n\nShunt difficult to palpate or shunt depth greater than 5 mm from the skin surface at the measurement location as determined by ultrasound.\n\nSubject-reported or documented history of serious adverse skin reactions to silicone-based adhesives.\n\nNew or worsening symptoms suggestive of shunt malfunction within the previous 7 days.\n\nUse of the study device would interfere with standard patient care, emergency surgery cannot be delayed, or study participation would interfere with optimal medical care.\n\nParticipation in another investigational procedural, pharmaceutical, or device study that may affect data collected in this study.\n\nPrevious participation in a Rhaeos clinical study using the current-generation RH05-B1 study device.\n\nFor participants with planned \"valve normal\" measurements only:\n\nInvestigator judges the participant is likely to be shunt independent (e.g., does not require a functional shunt for management of hydrocephalus).\n\nThis format follows ClinicalTrials.gov conventions by separating general criteria from those that apply only to specific participant subgroups.","ALL",{"count":18,"type":19},85,"ESTIMATED","INTERVENTIONAL",[22],"NA","Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can be difficult. Current diagnostic methods may require imaging studies or invasive procedures, which can be time-consuming, costly, or uncomfortable for patients.\n\nThe purpose of this study is to evaluate the performance of the Rhaeos Shunt Monitoring System (RSMS), an investigational wireless, noninvasive device designed to detect flow in implanted CSF shunts. The study will compare RSMS directly with ShuntCheck III, an FDA-cleared noninvasive device that is also used to assess CSF shunt flow. Both devices are placed on the skin over the shunt and use thermal sensing technology to evaluate whether fluid is flowing through the shunt.\n\nApproximately 85 pediatric and adult participants with an existing ventricular CSF shunt will be enrolled. Participants must have a functioning shunt and no recent symptoms suggesting shunt malfunction. Some participants with programmable shunt valves will have their valve temporarily adjusted to a manufacturer-provided \"virtual off\" setting, which is intended to substantially restrict shunt flow. These participants may also undergo measurements at their normal valve setting. Other participants will only undergo measurements at their normal valve setting.\n\nDuring the study visit, participants will undergo shunt flow assessments with both RSMS and ShuntCheck III. The order in which the devices are used will be randomized. Device measurements are collected while participants are seated upright, and participants and their treating clinicians will remain blinded to the measurement results. The study devices will not be used to make treatment decisions, and participation will not alter standard medical care. Adverse events associated with device use or valve adjustments will be monitored and recorded.\n\nThe primary goal of the study is to compare the ability of RSMS and ShuntCheck III to correctly identify shunts with flow-permissive (\"valve normal\") and restricted-flow (\"virtual off\") settings. Results from this study may help support the future development of a noninvasive tool to aid neurosurgeons in assessing CSF shunt flow. Participants are not expected to receive a direct medical benefit from taking part in the study.",[25],"Hydrocephalus",[27,28,29,30,31],"shunt","csf","cerebrospinal fluid","rhaeos","VP shunt","NOT_YET_RECRUITING","2026-06-25",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":19},"2026-06-30",{"date":40,"type":19},"2026-12-31",{"name":42,"class":43},"Rhaeos, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":44},"100629765","flow-detection-in-open-and-closed-shunt-valve-periods-100629765","NCT07478926","Flow Detection in Open and Closed Shunt Valve Periods","Detection of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Flow Detection Device During Open and Closed Shunt Periods","Inclusion Criteria:\n\nInclusion and Exclusion Criteria for Roll-In Subjects Inclusion criteria\n\n* Existing ventricular CSF shunt with an available \"virtual off\" setting which can be programmed noninvasively\n* 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\n* Signed informed consent by subject or a parent or legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n* Subject-reported or documented history of successful valve adjustment(s)\n\nInclusion and Exclusion Criteria for Main Study Subjects\n\nInclusion criteria\n\n* Existing ventricular CSF shunt\n* 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\n* Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n\nSubjects with planned \"virtual off\" measurement:\n\n-Existing ventricular CSF shunt with an available \"virtual off\" setting which can be programmed noninvasively\n\nSubjects with planned adjustment to the \"virtual off\" setting only:\n\n-Subject-reported or documented history of successful valve adjustment(s)\n\nExclusion Criteria:\n\nExclusion criteria\n\n* Presence of more than one distal shunt catheter in the study device measurement region\n* Presence of an interfering open wound or edema in the study device measurement region\n* Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement\n* Shunt valve is set to an opening pressure of \\>= 300 mm H2O, or the shunt system is otherwise set to substantially prevent shunt flow (e.g. Certas Plus valve programmed to a setting of 8 or a ligated shunt)\n* Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)\n* Subject has more than one intact and presumed functional distal catheter\n* Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives\n* Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days\n* 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\n* Prior enrollment in this study\n* Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study\n\nExclusion Criteria for Main Study Subjects Exclusion criteria\n\n* Presence of more than one distal shunt catheter in the study device measurement region\n* Presence of an interfering open wound or edema in the study device measurement region\n* Shunt is difficult to palpate, or the shunt depth at the device measurement location is deeper than 5 mm from the skin surface via ultrasound measurement\n* Subject-reported or documented history of serious adverse skin reactions to silicone-based adhesives\n* Subject-reported new or worsening symptoms of a possible shunt malfunction in the prior 7 days\n* 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\n* Prior enrollment in this study\n* Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study\n* Previous participation in a Rhaeos clinical study in which the study device (current generation) was used to acquire measurement data\n\nSubjects with planned \"valve normal\" measurements:\n\n* Shunt system is set to substantially prevent shunt flow (e.g. ligated shunt)\n* Investigator judges that the subject is likely to be shunt independent (e.g. does not require a functional shunt for management of hydrocephalus)\n* Subject has more than one intact and presumed functional distal catheter",{"count":53,"type":19},55,[22],"This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt. CSF shunts are commonly used to treat hydrocephalus, but it can be difficult to tell whether a shunt is working properly without invasive testing or imaging that does not directly measure flow.\n\nThe study device is a small, wireless sensor placed on the skin over the shunt tubing, typically near the collarbone. It uses gentle, controlled warmth to measure temperature changes that indicate whether fluid is flowing inside the shunt. The device does not break the skin and does not change a participant's medical care.\n\nThis study will enroll children and adults who already have a CSF shunt and who do not have new or worsening symptoms of shunt malfunction. All participants will have a measurement taken while their shunt valve is at its usual prescribed setting. Some participants with programmable shunt valves will also have a second measurement taken after their valve is temporarily adjusted to a setting intended to stop or greatly reduce flow (\"virtual off\"). After this measurement, the valve will be returned to its prescribed setting.\n\nThe study device results will not be shown to participants or their medical providers and will not be used to make treatment decisions. The goal of the study is to determine how well the device can distinguish between shunts that are allowing flow and those that are not.\n\nParticipants will be monitored for a short period after device use and, if applicable, after any valve adjustment. The main risks of participation are mild skin irritation from the adhesive or temporary symptoms related to valve adjustment. Participants are not expected to receive a direct medical benefit, but the information gained may help improve future diagnosis of shunt function.",[25],[58,59,27,60],"hydrocephalus","wearable","valve","RECRUITING","2026-03-12",{"date":64,"type":36},"2026-03-18",{"date":66,"type":36},"2026-01-27",{"date":40,"type":19},{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":20,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":44},"100596834","assessment-of-csf-shunt-flow-during-activities-of-daily-living-and-sleep-with-a-thermal-measurement-device-100596834","NCT07050628","Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device","Long-Term Tracking of Fluid Dynamics in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device During Activities of Daily Living Including Sleep","Inclusion Criteria:\n\n1. Existing ventricular CSF shunt\n2. (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure\n3. (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\n4. 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\n5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n6. Subject is at least 5 years old but \\\u003C 22 years old\n\nExclusion Criteria:\n\n1. Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation\n2. Presence of an interfering open wound or edema in the study device measurement region\n3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives\n4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n5. Investigator judges that the subject is unlikely to successfully take reliable measurements at home\n6. Investigator judges that the subject\u002Fsubject's caretaker would not be able to successfully place the device without assistance\n7. 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\n8. Prior enrollment in this study\n9. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study","5 Years","21 Years",{"count":79,"type":19},20,[22],"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",[25],"2025-06-25",{"date":85,"type":36},"2025-07-03",{"date":87,"type":19},"2025-07",{"date":89,"type":19},"2025-12",{"name":42,"class":43},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":20,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":44},"100592682","assessment-of-csf-shunt-flow-and-headaches-with-a-thermal-measurement-device-100592682","NCT06996600","Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device","Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches","Inclusion Criteria:\n\n1. Existing ventriculoperitoneal CSF shunt\n2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months\n3. 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\n4. Available for remote and in-person follow-up during the 30-day measurement period\n5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English\n7. Subject is at least 6 years old but not more than 80 years old\n\nExclusion Criteria:\n\n1. Presence of more than one distal shunt catheter in the study device measurement region\n2. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation\n3. Presence of an interfering open wound or edema in the study device measurement region\n4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives\n5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home\n7. Investigator judges that the subject\u002Fsubject's caretaker would not be able to successfully place the device without assistance\n8. 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\n9. Prior enrollment in this study\n10. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study","6 Years","80 Years",{"count":101,"type":19},29,[22],"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 headache and non-headache periods.",[25],"2025-05-29",{"date":107,"type":36},"2025-05-30",{"date":109,"type":36},"2025-05-02",{"date":89,"type":19},{"name":42,"class":43},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":44},"100593666","assessment-intravenous-site-events-during-outpatient-infusion-procedures-with-a-wireless-thermal-measurement-device-during-100593666","NCT07009405","Assessment Intravenous Site Events During Outpatient Infusion Procedures With a Wireless Thermal Measurement Device During","Continuous Monitoring of Intravenous Site Events With a Wireless Thermal Measurement Device During Outpatient Infusion Procedures","Inclusion Criteria:\n\n1. Scheduled to receive an infusion therapy of at least 30 minutes in length\n2. Region of intact skin proximal to the infusion catheter insertion site that is appropriate in size for application of the study device\n3. Signed informed consent\n4. Available for 15 minutes of post-measurement monitoring following removal of the study device\n\nExclusion Criteria:\n\n1. Patient is under 12 years of age\n2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives or Tegaderm\n3. Use of the study device would interfere with standard patient care that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject\n4. Investigator judges that the intravenous","12 Years",{"count":121,"type":19},10,[22],"This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.",[125,126],"IV Infiltration","IV Extravasation",{"date":128,"type":36},"2025-06-06",{"date":130,"type":36},"2025-05-28",{"date":89,"type":19},{"name":42,"class":43},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":149,"locationsCount":44},"100547539","assessment-of-flow-in-cerebrospinal-fluid-shunts-with-a-second-generation-wireless-thermal-anisotropy-measurement-device-100547539","NCT06409286","Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device","Inclusion Criteria:\n\n1. Existing ventriculoperitoneal CSF shunt on which the subject is dependent\n2. 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\n3. Exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data\n4. 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\n5. Available for follow-up for up to seven days\n6. Signed informed consent by subject 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)\n\nExclusion Criteria:\n\n1. Presence of more than one distal shunt catheter in the study device measurement region\n2. Presence of an interfering open wound or edema in the study device measurement area\n3. Subject-reported history of adverse skin reactions to adhesives\n4. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n5. Participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject\n6. Previous participation in a Rhaeos clinical study in which FlowSense device measurement data were acquired\n7. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study",{"count":140,"type":19},17,"OBSERVATIONAL","This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.",[25],"2025-05-12",{"date":146,"type":36},"2025-05-15",{"date":87,"type":19},{"date":89,"type":19},{"name":42,"class":43},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":20,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":44},"100547662","assessment-of-flow-in-cerebrospinal-fluid-shunts-with-a-wireless-thermal-anisotropy-measurement-device-in-asymptomatic-patients-100547662","NCT06410885","Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients","Inclusion criteria\n\n1. Existing ventricular cerebrospinal fluid shunt\n2. Age ≥ 2 years old\n3. 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\n4. Capable of providing informed consent or have a legal guardian, health care agent, or surrogate decision-maker able to provide informed consent\n5. Standard of care outpatient visit with neurosurgeon assessment of having \"no clinical concern for shunt malfunction\"\n\nExclusion criteria\n\n1. Subject not scheduled to receive outpatient standard of care imaging (CT, MRI, X-ray shunt series) as part of the clinic visit\n2. Presence of more than one distal shunt catheter in the study device measurement region\n3. Presence of an interfering open wound or edema in the study device measurement region\n4. Subject-reported history of adverse skin reactions to silicone adhesives\n5. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject\n6. Subject not available for seven-day follow-up","2 Years",{"count":158,"type":19},60,[22],"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).",[25],{"date":146,"type":36},{"date":164,"type":19},"2025-06",{"date":166,"type":19},"2026-05",{"name":42,"class":43},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":99,"enrollmentInfo":174,"targetDuration":4,"studyType":20,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":184},"100522741","longitudinal-measurements-of-flow-in-cerebrospinal-fluid-shunts-with-a-wireless-thermal-anisotropy-measurement-device-100522741","NCT06086561","Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device","Inclusion Criteria:\n\n1. At least one existing ventricular CSF shunt (functional or non-functional, including \"virtual off\" and ligated, orphaned, abandoned, tied-off, or fractured distal catheters)\n2. Region(s) of intact skin overlying at least one unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device\n3. Available for remote and in-person follow-up during the 30-day measurement period (for subjects using the study device at home)\n4. Subject is expected to remain in an inpatient setting for sufficient time to complete all required study device measurements (for subjects using the device in an inpatient hospital setting)\n5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English\n7. Verbal assent by minors 12 years of age and older who are able to understand the study and communicate their decision\n8. Patient is at least 5 years old but not more than 80 years old\n\nExclusion Criteria:\n\n1. Presence of an interfering open wound or edema over any portion of the shunt\n2. Patient-reported history of adverse skin reactions to adhesives\n3. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable\n4. Investigator judges that the subject is unlikely to successfully take reliable measurements at home (for subjects using the study device at home)\n5. Investigator judges that the subject\u002Fsubject's caretaker would not be able to successfully place the device without assistance\n6. 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\n7. Participation in any other investigational procedural, pharmaceutical, and\u002For device study that may influence the collection of valid data under this study",{"count":175,"type":19},130,[22],"This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.",[25],{"date":146,"type":36},{"date":181,"type":36},"2023-11-17",{"date":89,"type":19},{"name":42,"class":43},4,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":16,"minAge":76,"maxAge":99,"enrollmentInfo":193,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":44},"100519219","formative-usability-assessment-of-wireless-thermal-anisotropy-devices-100519219","NCT06040697","Formative Usability Assessment of Wireless Thermal Anisotropy Devices","Formative Usability Assessment of Wireless Thermal Anisotropy Devices Measuring Flow in Cerebrospinal Fluid Shunts","Inclusion Criteria:\n\n1. Existing ventricular CSF shunt with a region of intact skin overlying the shunt catheter appropriate in size for application of the study device\n2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)\n3. Subject or caregiver can clearly communicate and document information in English\n4. Verbal assent by minors 12 years of age and older who can understand the study and communicate their decision\n5. Subject is at least 5 years old but not more than 80 years old\n\nExclusion Criteria:\n\n1. Presence of an interfering open wound in the device application region\n2. Subject-reported history of adverse skin reactions to adhesives",true,{"count":194,"type":19},145,"Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.",[25],{"date":146,"type":36},{"date":199,"type":36},"2023-09-29",{"date":89,"type":19},{"name":42,"class":43},""]