[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561642":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":95,"collaborators":10,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":10,"enrollmentInfo":107,"targetDuration":10,"studyType":110,"phases":10,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Olympus Corporation of the Americas","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All subjects enrolled",null,"Consecutive, eligible patients reporting for an endoscopic ultrasound liver biopsy and FibroScan for evaluation of liver fibrosis will be enrolled. EUS-SWE\u002FATI will be compared to liver biopsy pathology results, FibroScan (VCTE and CAP) results, and screening scores).",[13,14,15],"Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging","Device: FibroScan","Device: Liver biopsy",[17,24,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging","EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).",[9],[23],"EUS-SWE\u002FATI",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"FibroScan","A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.",[9],{"type":18,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Liver biopsy","A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically.\n\nEndoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.",[9],[33],"EUS-guided LB",[35],{"name":36,"affiliation":37,"role":38},"Marvin Ryou, MD","Brigham and Women's Hospital, Boston, MA","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Octavia Plingu","CONTACT","4089413623","octavia.plingu@olympus.com",{"name":46,"role":42,"phone":47,"phoneExt":10,"email":48},"Jewel Gill","9196333967","Jewel.Gill@olympus.com",[50,74],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Brigham and Women's Hospital","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65,69,73],{"name":66,"role":42,"phone":67,"phoneExt":10,"email":68},"Michele Ryan, MS","617-676-5928","mryan@bwh.harvard.edu",{"name":70,"role":42,"phone":71,"phoneExt":10,"email":72},"Samantha Geltz","843-290-4268","sgeltz@bwh.harvard.edu",{"name":36,"role":38,"phone":10,"phoneExt":10,"email":10},{"facility":75,"status":52,"city":76,"state":77,"zip":78,"country":56,"countryCode":57,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Geisinger Medical Center","Danville","Pennsylvania","17822",{"type":59,"coordinates":80},[81,82],-76.61273,40.96342,{"lat":82,"lon":81},[85,89,93],{"name":86,"role":42,"phone":87,"phoneExt":10,"email":88},"Kali Rebuck","570-214-1186","krebuck@geisinger.edu",{"name":90,"role":42,"phone":91,"phoneExt":10,"email":92},"Nikolas Antinnes","5702141186","nantinnes@geisinger.edu",{"name":94,"role":38,"phone":10,"phoneExt":10,"email":10},"Khara Harshit, MD",{"type":96,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100561642","endoscopic-ultrasound-shear-wave-elastography-study-100561642",false,"NCT06592820","Endoscopic Ultrasound Shear Wave Elastography Study","Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease","EUS-SWE","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure\u002Fsurgery or weight change of \\>10% total body weight\n5. BMI \\>\u002F=28\n6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and\u002For 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)\n\nExclusion Criteria:\n\n1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma\n2. Prior history of Hepatitis B or C infection\n3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)\n4. Histological evidence of other concomitant chronic liver disease on biopsy\n5. Inadequate liver biopsy\n6. Prior history of or current excess alcohol consumption (\\>140 g\u002Fweek and \\>210 g\u002Fweek for females and males, respectively) documented in EMR","ALL","18 Years",{"count":108,"type":109},300,"ESTIMATED","OBSERVATIONAL","This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\\[s\\] it aims to answer are:\n\n* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis\n* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).\n\nParticipants will undergo:\n\n* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)\n* Liver biopsy\n* FibroScan",[113,114,115,116],"MASLD","MASH","Fibrosis, Liver","Chronic Liver Disease",[118,119,25,120],"Shear Wave Elastography","Shear Wave","Attenuation Imaging","2025-09-11",{"date":123,"type":124},"2025-09-15","ACTUAL",{"date":126,"type":124},"2025-09-03",{"date":128,"type":109},"2027-03-28",{"name":5,"class":6},2]