[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02897908":3,"trial-entities:NCT02897908":88,"trial-summary:NCT02897908":92},{"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":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":45,"maximum_age":21,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":58,"locations":61,"central_contacts":79,"overall_officials":85,"references":86,"see_also_links":87},"NCT02897908","FibroScan","Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis\u002FFibrosis Database","RECRUITING","2027-04","2026-05","2026-06-22","2016-10-28","State University of New York at Buffalo","OTHER",false,"The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.","The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.",[18],"Disease of Liver and Bile Duct",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},1000,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"PROCEDURE","vibration controlled transient elastography (VCTE)","Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from a given VCTE exam is the median value of at least 10 successful measurements. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.",[32],"liver fibrosis and steatosis",[34],"fibroscan",[36],{"measure":37,"description":38,"timeFrame":39},"measurement of fibrosis in patients with varying degrees of liver disease","single event per patient with liver disease to measure degree of fibrosis concentration","10 years",[41],{"measure":42,"description":43,"timeFrame":39},"measurement of liver fat in patients with varying degrees of liver disease","single event per patient with liver disease to measure degree of fat concentration","ALL","18 Years",{"inclusion":47,"exclusion":51,"raw_text":57},[48,49,50],"Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis","Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring","Subjects who have other known liver diseases ie: HCV",[52,53,54,55,56],"Patients less than 18 years of age","Pregnancy","Patients that do not want to be contacted for consideration in future research studies.","Patients diagnosed with ascites or peritoneal dialysis","Body mass index (BMI) ≥40","Inclusion Criteria:\n\n* Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis\n* Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring\n* Subjects who have other known liver diseases ie: HCV\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Pregnancy\n* Patients that do not want to be contacted for consideration in future research studies.\n* Patients diagnosed with ascites or peritoneal dialysis\n* Body mass index (BMI) ≥40",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":7,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":76},"Conventus Medical Office Building","Buffalo","New York","14203","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Ajay Chaudhuri, MD","CONTACT","716-907-1916","achaudhu@buffalo.edu",{"name":70,"role":75},"PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},42.88645,-78.87837,[80,81],{"name":70,"role":71,"phone":72,"email":73},{"name":82,"role":71,"phone":83,"email":84},"Andrew Talal, MD","716-888-4737","ahtalal@buffalo.edu",[],[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Liver and Intrahepatic Bile Duct Disorder",[],{"nct_id":4,"found":93,"summary":94,"prompt_version":104},true,{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study aiming to enroll 1000 participants. It is not a treatment study but collects information for future research.","completed","Liver Screening with FibroScan for Liver Disease Database","This study is creating a database of information from people with different types and stages of liver disease. Researchers will use a non-invasive device called FibroScan (vibration controlled transient elastography or VCTE) to measure liver stiffness and the amount of fat in the liver. This information, along with your medical history, will be added to a database for future research. You may be able to join if you are 18 or older and have known risk factors for fatty liver (steatosis) or liver scarring (fibrosis), a previous diagnosis of Non-Alcoholic Steatohepatitis (NASH) without current scoring, or other liver diseases like HCV. The main goal is to measure liver scarring in patients over 10 years to build this database.","Liver fibrosis measurements will be taken at 10 years, suggesting a long-term follow-up for data collection.",118,"You would have one FibroScan measurement. Researchers will also collect information about your demographics, medical history, and lab results.","Not stated in the trial record.",[],"v2"]