[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653884":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":35,"interventions":43,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":27,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":27,"enrollmentInfo":101,"targetDuration":27,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":112,"whyStopped":27,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Tumor Absorbed Dose (Gy)","Tumor absorbed dose (Gy) measured using post-radioembolization \\^90Y PET\u002FCT and Simplicit90Y dosimetry analysis software. The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.","Within 1 day following intervention",[14,17,21,24],{"measure":15,"description":16,"timeFrame":12},"Tumor-to-Normal Liver Ratio (T\u002FN Ratio)","T\u002FN ratio measured on post-radioembolization \\^90Y PET\u002FCT using Simplicit90Y dosimetry analysis software. This endpoint evaluates preferential microsphere deposition within tumor relative to normal liver tissue and compares results between treatment groups.",{"measure":18,"description":19,"timeFrame":20},"Objective Response Rate (ORR) by RECIST 1.1","Proportion of target lesions achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.","3 months and 6 months after radioembolization",{"measure":22,"description":23,"timeFrame":20},"Disease Control Rate (DCR) by RECIST 1.1","Proportion of target lesions achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.",{"measure":25,"description":26,"timeFrame":20},"Tumor Response by mRECIST for enhancing tumors","For tumors demonstrating arterial enhancement on pre-treatment imaging, treatment response will be assessed using mRECIST criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":27,"timePerspective":27,"maskingInfo":33},"NA","SINGLE_GROUP","Randomization occurs at the Y-90 delivery site level within participants, not between participant groups.","TREATMENT",{"masking":34,"maskingDescription":27,"whoMasked":27},"NONE",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"Single Group","EXPERIMENTAL","Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant.",[41,42],"Device: The TriNav Infusion Systems","Device: Standard End Hole Microcatheter",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":27},"DEVICE","The TriNav Infusion Systems","The Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e. MIM SurePlan or Simplicit90y)",[37],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":27},"Standard End Hole Microcatheter","The comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications. The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y).",[37],[54],{"name":55,"affiliation":5,"role":56},"Matthew Hung, MD","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":27,"email":62},"Brittney Worley","CONTACT","650-736-3688","bw718@stanford.edu",{"name":64,"role":60,"phone":27,"phoneExt":27,"email":65},"David Marcellus","dmarcel2@stanford.edu",[67],{"facility":5,"status":27,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Palo Alto","California","94305","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-122.14302,37.44188,{"lat":77,"lon":76},[80,82,84],{"name":81,"role":60,"phone":61,"phoneExt":27,"email":62},"Brittney G Worley",{"name":83,"role":60,"phone":27,"phoneExt":27,"email":65},"David G Marcellus, MD",{"name":85,"role":56,"phone":27,"phoneExt":27,"email":27},"Matthew Hung",{"type":87,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[89],{"name":90,"class":91},"TriSalus Life Sciences, Inc.","INDUSTRY","100653884","end-hole-vs-pressure-modulated-delivery-of-y-90-resin-microspheres-to-liver-metastases-100653884",false,"NCT07791446","End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.","Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.","Inclusion Criteria:\n\n1. Presence of multiple liver metastases\n2. Prior multidisciplinary clinical decision for treatment with radioembolization\n3. 18 years of age or older\n4. ECOG less than or equal to 2\n5. Life expectancy \\> 3 months\n6. Ability to understand and the willingness to provide written informed consent.\n7. At least 2 planned Y-90 delivery sites\u002Fvessels with the same target mean dose to tumor\n8. Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria\n9. At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.\n10. Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.\n11. The vessel level for each planned delivery site is no further distal than the segmental level.\n\nExclusion Criteria:\n\n1. Pregnant\n2. Breast-feeding\n3. Lung shunt fraction \\> 20% or calculated lung dose \\> 30 Gy\n4. Prior hepatic transarterial embolization in the hepatic lobe to be treated","ALL","18 Years",{"count":102,"type":103},65,"ESTIMATED","INTERVENTIONAL",[29],"Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.\n\nA standard of care post-Y-90 PET\u002FCT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST\u002FmRECIST criteria.",[108,109],"Liver Metastases","Tumor",[111,46],"Y-90","NOT_YET_RECRUITING","2026-08-24",{"date":115,"type":116},"2026-08-28","ACTUAL",{"date":118,"type":103},"2026-11",{"date":120,"type":103},"2029-11",{"name":5,"class":6},1]