[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06410885":3,"trial-entities:NCT06410885":77,"trial-summary:NCT06410885":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":43,"minimum_age":44,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":45,"std_ages":49,"locations":53,"central_contacts":69,"overall_officials":74,"references":75,"see_also_links":76},"NCT06410885","2023-03","Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients","NOT_YET_RECRUITING","2026-05","2025-05","2025-05-15","2025-06","Rhaeos, Inc.","INDUSTRY",false,"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).",null,[18],"Hydrocephalus",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"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.",[33,34],"Diagnostic, part 2 (unblinded)","Observational, part 1 (blinded)",[36],{"measure":37,"description":38,"timeFrame":39},"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",[41],{"measure":42,"description":38,"timeFrame":39},"Study device sensitivity, specificity, diagnostic accuracy, and positive predictive value (PPV)","ALL","2 Years",{"inclusion":46,"exclusion":47,"raw_text":48},[],[],"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",[50,51,52],"CHILD","ADULT","OLDER_ADULT",[54],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":66},"UCSF Benioff Children's Hospital","San Francisco","California","94158","United States",[61],{"name":62,"role":63,"phone":64,"email":65},"Catalina Pen","CONTACT","415-353-2342","catalina.pen@ucsf.edu",{"lat":67,"lon":68},37.77493,-122.41942,[70],{"name":71,"role":63,"phone":72,"email":73},"Anna Lisa Somera","855-814-3569","info@rhaeos.com",[],[],[],{"nct_id":4,"conditions":78,"biomarkers":79},[18],[],{"nct_id":4,"found":81,"summary":82,"prompt_version":92},true,{"design":83,"status":84,"heading":85,"summary":86,"follow_up":87,"word_count":88,"commitments":89,"compensation":90,"drugs_mentioned":91},"This is an interventional study planning to enroll 60 participants. It involves a blinded part (Part 1) and an unblinded part (Part 2).","completed","Assessment of FlowSense® for Hydrocephalus Shunts","This study is testing a new, non-invasive device called FlowSense® that can check the flow in cerebrospinal fluid (CSF) shunts. These shunts are used to treat hydrocephalus, a condition where there's too much fluid around the brain. The FlowSense® device is placed on your skin over your existing shunt. The study aims to see how well FlowSense® can correctly identify when a shunt is working properly (its negative predictive value). You might be able to join if you are at least 2 years old, have an existing CSF shunt, and have a suitable area of skin over your shunt for the device. The study is currently unclear about its recruitment status.","The primary outcome, negative predictive value, is measured up to 7 days.",111,"You would have the FlowSense® device placed on your skin over your shunt during an outpatient visit. The study will also look at changes in imaging, healthcare use, and visit length during your routine follow-up appointments.","Not stated in the trial record.",[],"v2"]