[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100280677":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":33,"locations":39,"responsibleParty":53,"collaborators":37,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":37,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":37,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":82,"overallStatus":89,"whyStopped":37,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"St. Louis University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NASH- Left gastric artery embolization","EXPERIMENTAL","Embospheres Microspheres as artificial embolic agent for left gastric artery embolization",[13],"Device: Embospheres Microspheres",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Embospheres Microspheres","Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.",[9],[21],"Bariatric embolization",[23,27,30],{"name":24,"affiliation":25,"role":26},"Keith Pereira, MD","Assistant professor of radiology-Interventional radiology","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Brent Neuschwander-Tetri, MD","Professor of medicine- gastroenterology",{"name":31,"affiliation":32,"role":26},"Kirubahara Vaheesan, MD","Assistant professor of radiology- Interventional radiology",[34],{"name":24,"role":35,"phone":36,"phoneExt":37,"email":38},"CONTACT","314-268-5558",null,"keith.pereira@health.slu.edu",[40],{"facility":41,"status":37,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":37},"Saint Louis University","St Louis","Missouri","63110","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-90.19789,38.62727,{"lat":51,"lon":50},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","Keith Pereira, MD:","MD","100280677","bariatric-embolization-of-arteries-for-the-treatment-of-nonalcoholic-steatohepatitis-100280677",false,"NCT02933554","Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis","A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization, to Promote Short-term Weight Loss in Obese Patients With Nonalcoholic Steatohepatitis (NASH) and Thereby Improve NASH","Inclusion Criteria:\n\n1. Male or Female, aged 22 years or older.\n2. Willing, able and mentally competent to provide written informed consent and willing to comply with all study procedures and be available for the duration of the study\n3. BMI \\>35 kg\u002Fm2\n4. Adequate hematological, hepatic and renal function as follows:\n\n   1. Hematological: Hematological: If the bariatric embolization procedure is being performed by femoral access: platelets \\> 50 x 109\u002FL, INR \\\u003C1.5. If the bariatric embolization procedure is being performed by radial access: platelets \\>35 x 109\u002FL and INR \\\u003C1.5 OR platelets \\>50 x 109\u002FL and INR between 1.5 and 2.\"\n   2. Hepatic : Total bilirubin \\\u003C3 mg\u002FdL\n   3. Renal: Estimated GFR \\> 60ml\u002Fmin.1.73m2\n5. If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\n6. Elevated alanine or aspartate aminotransferase values (ALT \\>41 or AST\\>34 U\u002FL).\n7. Liver biopsy showing evidence of NASH in the past 12 months.\n8. No evidence of another form of liver disease.\n9. Patients diagnosed with NASH and have evidence of failing other methods of weight loss through diet, exercise and behavior modification.\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Active substance abuse\n3. Significant psychiatric problems, severe enough to cause suffering or a poor ability to function in life. Center for Epidemiological Studies Depression (CESD) score \\> or = 16 without psychiatric evaluation. \\[If Center for Epidemiological Studies Depression (CESD) score \\> or =16 AND is in care of behavior health specialist who has indicated patient has adequate coping mechanisms to undergo procedure and does not foresee mental health as barrier to participation in study.\\]\n4. Significant alcohol consumption ( \\>20 g\u002Fday in women, \\>30 g\u002Fday in men)\n5. Weight \\> 400 lbs, BMI \\> 50 kg\u002Fm2.\n6. Contraindications to obtaining a liver biopsy\n7. Subjects with pre-existing abdominal pain will be excluded (because of the potential confusion with pain related to the procedure).\n8. Subjects who are intolerant to PPIs\n9. Subjects requiring any anticoagulant medications should be excluded if radial access cannot be obtained.\n10. Subjects with platelets \\\u003C35 x 109\u002FL and INR \\> 2.0\n11. Subjects who are taking aspirin\u002F NSAIDs and in whom these medications are unable to be withdrawn from aspirin and NSAIDs for at least 3 days prior to the LGAE procedure and for 30 days following the LGAE procedure (because of the potential risks of gastric bleeding following the procedure).\n12. Presence of systemic illness or other medical conditions relevant to survival .(Note that in the HCC pre liver transplant cohort, the presence of HCC will not be considered an exclusion criteria)\n13. Metastatic cancer\n14. Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled spontaneous encephalopathy)\n15. prior surgical weight loss procedures including gastroplasty, jejunoileal, or jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history of gastric pancreatic, hepatic, and\u002For splenic surgery\n16. Prior embolization to the stomach, spleen or liver, unless the prior embolization was a transarterial chemoembolization (TACE) to the liver for HCC.\n17. If review of available prior imaging studies (i.e CT, MRI, or US)shows potential anatomical variations, presence of severe atheromatous disease, large arteriovenous shunting of blood.\n18. Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active peptic ulcer disease, active H. pylori infection\n19. History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying of gastric contents \\> 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.\n20. ASA Class 4 or 5\n21. Child Pugh classification C\n22. Known aortic disease, such as dissection or aneurysm; peripheral arterial disease or other cardiovascular disease.\n23. Type 2 diabetes on anti-diabetic medications that are known to cause hypoglycemia. e.g. sulphonylureas, meglitinides\n24. Patients with a known other cause for their increased liver enzyme levels such as viral hepatitis (B or C), autoimmune\u002Fchronic immune hepatitis, primary biliary cholangitis, metabolic and genetic hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency\n25. Patient taking hepatotoxic drugs. List of drugs causing steatohepatitis include but are not limited to: amiodarone, chemotherapy (5-fluorouracil, tamoxifen, irinotecan, cisplatin, and asparaginase), glucocorticoids, methotrexate, sulfonamides, antithyroid drugs, phenytoin, tetracyclines, isoniazid, salicylates, and valproic acid.\n26. Contraindications to obtaining a liver biopsy (NASH cohort)\n27. Patients taking other trial medications for NASH.",true,"ALL","22 Years","65 Years",{"count":69,"type":70},8,"ESTIMATED","INTERVENTIONAL",[73],"NA","Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant.\n\nRecent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.",[76,77,78,79,80,81],"Obesity","Weight Loss","Body Weight","Nonalcoholic Steatohepatitis","Nonalcoholic Fatty Liver Disease","NAFLD",[83,84,85,86,87,88],"bariatric surgery","minimally invasive","Embolization","NASH","ghrelin","gastric artery embolization","NOT_YET_RECRUITING","2025-07-23",{"date":92,"type":93},"2025-07-28","ACTUAL",{"date":95,"type":70},"2025-12",{"date":97,"type":70},"2027-06",{"name":55,"class":6},1]