[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655857":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":58,"studyPopulation":58,"armGroups":61,"interventions":67,"overallOfficials":73,"centralContacts":78,"locations":83,"responsibleParty":210,"collaborators":212,"id":218,"slug":219,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":58,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":58,"enrollmentInfo":227,"targetDuration":58,"studyType":230,"phases":231,"briefSummary":232,"conditions":233,"keywords":243,"overallStatus":86,"whyStopped":58,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},{"fullName":5,"class":6},"Banner Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"To assess the success of energy delivery during treatment with the device","Success of energy delivery as measured by presence of echogenic microbubbles visualized during EUS imaging AND generator-confirmed energy delivery.","From first MWA procedure to the end of treatment at Week 5 or 9",[14,18,21,24,28],{"measure":15,"description":16,"timeFrame":17},"To evaluate the procedural safety","Procedural safety as measured by absence of unplanned terminations or major complications during or immediately following (within 2 weeks) of ablation procedure.","From first MWA treatment to final long term follow up at week 52",{"measure":19,"description":20,"timeFrame":17},"To evaluate clinical safety","Clinical safety as measured by occurrence and severity of AEs, SAEs, and ADEs related to the procedure.",{"measure":22,"description":23,"timeFrame":17},"To evaluate tolerability of treatment with the device","Tolerability as measured by patient-reported Numeric Pain Rating Scale pain score. Numeric Pain Rating Scale is scored 0-10, where \"0\" represents \"no pain\" and \"10\" represents \"worst pain imaginable.\"",{"measure":25,"description":26,"timeFrame":27},"To evaluate the early antitumor effect of treatment with the device by change in size of target lesion.","Early antitumor effect at 3 months and 6 months as measured by percent change in target lesion diameter on CT\u002FMRI or maximal lesion diameter on EUS.","From first MWA treatment to follow up visit at 6 months from first treatment",{"measure":29,"description":30,"timeFrame":31},"To evaluate the early antitumor effect of treatment with the device by RECIST.","Early antitumor effect at 3 months and 6 months as measured by Objective response rate (ORR), defined as complete response (CR) + partial response (PR) on CT\u002FMRI, per Response Evaluation Criteria in Solid Tumors (RECIST).","Time Frame: From first MWA treatment to follow up visit at 6 months from first treatment",[33,37,41,45,49],{"measure":34,"description":35,"timeFrame":36},"To evaluate the technical success of the device","Technical success of device as measured by reaching intended target tissue, successful delivery of MWA energy, and EUS imaging-confirmed achievement of ablation.","From first MWA treatment to final treatment at Week 5 or 9",{"measure":38,"description":39,"timeFrame":40},"To evaluate the correlation between changes in tumor marker CA 19-9 and antitumor effect of treatment with the device by change in size of target lesion (if data are available)","Correlation between change in tumor markers, as measured by change in serum CA 19-9 tumor marker levels from baseline to EOS follow up at Week 26 or 52, and antitumor effect of treatment, as described in Secondary Outcome Measure #5.","From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52",{"measure":42,"description":43,"timeFrame":44},"To evaluate the correlation between changes in tumor marker CA 19-9 and antitumor effect of treatment with the device by RECIST (if data are available)","Correlation between change in tumor markers, as measured by change in serum CA 19-9 tumor marker levels from baseline to EOS follow up at Week 26 or 52, and antitumor effect of treatment, as described in Secondary Outcome Measure #6.","Time Frame: From first MWA treatment to End of Study (EOS) follow up at Week 26 or 52",{"measure":46,"description":47,"timeFrame":48},"To evaluate the long-term antitumor effect of treatment with the device (if data are available) by change in size of target lesion.","Long-term antitumor effect as measured by percent change in target lesion diameter on CT\u002FMRI or maximal lesion diameter on EUS after 1-year follow-up.","From first MWA treatment to long term follow up visit at Week 52",{"measure":50,"description":51,"timeFrame":52},"To evaluate the long-term antitumor effect of treatment with the device (if data are available) by RECIST.","Long-term antitumor effect as measured by ORR, defined as CR + PR on CT\u002FMRI per RECIST, after 1-year follow-up.","Time Frame: From first MWA treatment to long term follow up visit at Week 52",{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":58,"timePerspective":58,"maskingInfo":59},"NA","SINGLE_GROUP","This is a prospective feasibility study; therefore, no randomization is being performed.","TREATMENT",null,{"masking":60,"maskingDescription":58,"whoMasked":58},"NONE",[62],{"label":63,"type":6,"description":64,"interventionNames":65},"Endoscopic Ultrasound (EUS) - Guided Microwave Ablation (MWA) Device Group","This is a open label feasibility study and only eligible participants will be enrolled into the single arm of the study to receive MWA with this specific device.",[66],"Device: EUS-Guided MWA Device",[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":58},"DEVICE","EUS-Guided MWA Device","The rationale of this study is to generate preliminary data on the functionality and safety of Creo's MicroBlate™ Fine device when used under EUS guidance. The results generated from this study will inform any decisions regarding subsequent pivotal trials and may support the integration of this approach into clinical practice for anatomically challenging tumors.",[63],[74],{"name":75,"affiliation":76,"role":77},"Neil Sharma, MD","Banner Health (Banner MD Anderson Cancer Center at Gateway Medical Center)","PRINCIPAL_INVESTIGATOR",[79],{"name":75,"role":80,"phone":81,"phoneExt":58,"email":82},"CONTACT","(480) 356 - 6444","neil.sharma@bannerhealth.com",[84,101,119,136,156,173,193],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Banner MD Anderson Cancer Center and Gateway Hospital","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":93,"coordinates":94},"Point",[95,96],-111.78903,33.35283,{"lat":96,"lon":95},[99],{"name":75,"role":80,"phone":100,"phoneExt":58,"email":82},"480-256-6444",{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":90,"countryCode":91,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Cedars Sinai","NOT_YET_RECRUITING","Los Angeles","California","90048",{"type":93,"coordinates":108},[109,110],-118.24368,34.05223,{"lat":110,"lon":109},[113,117],{"name":114,"role":80,"phone":115,"phoneExt":58,"email":116},"Sara Karameh","310-423-6082","Sara.karameh@cshs.org",{"name":118,"role":77,"phone":58,"phoneExt":58,"email":58},"Barham Abu Dayyeh, MD",{"facility":120,"status":103,"city":121,"state":122,"zip":123,"country":90,"countryCode":91,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Rush University Medical Center","Chicago","Illinois","60607",{"type":93,"coordinates":125},[126,127],-87.65005,41.85003,{"lat":127,"lon":126},[130,134],{"name":131,"role":80,"phone":132,"phoneExt":58,"email":133},"Amanda Lin","312-563-3907","Amanda_F_Lin@rush.edu",{"name":135,"role":77,"phone":58,"phoneExt":58,"email":58},"Ajay Singh, MD",{"facility":137,"status":103,"city":138,"state":139,"zip":140,"country":90,"countryCode":91,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"type":93,"coordinates":142},[143,144],-92.4699,44.02163,{"lat":144,"lon":143},[147,151,153],{"name":148,"role":80,"phone":149,"phoneExt":58,"email":150},"Elizabeth Lemke","507-266-3317","Lemke.Elizabeth@mayo.edu",{"name":152,"role":77,"phone":58,"phoneExt":58,"email":58},"Vinay Chandrasekhara, MD",{"name":154,"role":155,"phone":58,"phoneExt":58,"email":58},"Jad Abimansour, MD","SUB_INVESTIGATOR",{"facility":157,"status":103,"city":158,"state":159,"zip":160,"country":90,"countryCode":91,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"University of Tennessee Medical","Knoxville","Tennessee","37920",{"type":93,"coordinates":162},[163,164],-83.92074,35.96064,{"lat":164,"lon":163},[167,171],{"name":168,"role":80,"phone":169,"phoneExt":58,"email":170},"Brandy Herbert","865-305-5120","bherbert@utmck.edu",{"name":172,"role":77,"phone":58,"phoneExt":58,"email":58},"Frank Gress, MD",{"facility":174,"status":103,"city":175,"state":176,"zip":177,"country":90,"countryCode":91,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Memorial Hermann-Texas Medical Center","Houston","Texas","77030",{"type":93,"coordinates":179},[180,181],-95.36327,29.76328,{"lat":181,"lon":180},[184,188,191],{"name":185,"role":80,"phone":186,"phoneExt":58,"email":187},"Cecelia Lara","713-500-6529","Cecilia.Lara@uth.tmc.edu",{"name":189,"role":80,"phone":58,"phoneExt":58,"email":190},"Nicole Fatheree","Nicole.Fatheree@uth.tmc.edu",{"name":192,"role":77,"phone":58,"phoneExt":58,"email":58},"Nirav Thosani, MD",{"facility":194,"status":103,"city":195,"state":196,"zip":197,"country":90,"countryCode":91,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"West Virginia University Medicine","Morgantown","West Virginia","26506",{"type":93,"coordinates":199},[200,201],-79.9559,39.62953,{"lat":201,"lon":200},[204,208],{"name":205,"role":80,"phone":206,"phoneExt":58,"email":207},"Chad Glaze","304-293-9195","cglaze@hsc.wvu.edu",{"name":209,"role":77,"phone":58,"phoneExt":58,"email":58},"Shailendra Singh, MD",{"type":211,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[213,216],{"name":214,"class":215},"Creo Medical Limited","INDUSTRY",{"name":217,"class":215},"CreoMed, Inc.","100655857","creo---microwave-ablation-feasibility-study-100655857",false,"NCT07817147","CREO - Microwave Ablation Feasibility Study","Investigator-Initiated Feasibility Study of a Novel Endoscopic Ultrasound Guided Microwave Ablation Device in Patients With Locally Advanced, Unresectable, or Metastatic Cancer","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Willing and able to provide written informed consent\n* Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV)\n* At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc).\n* The tumor(s) must be ≥1 cm in diameter\n\nExclusion Criteria:\n\n* Participant is a candidate for upfront resection of pancreatic cancer\n* Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study\n* Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being","ALL","18 Years",{"count":228,"type":229},75,"ESTIMATED","INTERVENTIONAL",[54],"The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural\u002Fclinical safety of treatment with the device and the antitumor effect following treatment with the device.",[234,235,236,237,238,239,240,241,242],"Pancreatic Cancer","Liver Cancer (Locally Advanced or Metastatic)","Pancreatic Cancer Non-resectable","Pancreatic Cancer Stage III","Pancreatic Cancer Stage IV","Liver Cancer Stage IV","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc",[244,245,246],"Locally Advanced","Unresectable","Metastatic","2026-09-08",{"date":249,"type":250},"2026-09-14","ACTUAL",{"date":252,"type":250},"2026-02-19",{"date":254,"type":229},"2028-08",{"name":5,"class":6},7]