[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06188585":3,"trial-entities:NCT06188585":264,"trial-summary:NCT06188585":269},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":50,"secondary_outcomes":55,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":78,"locations":81,"central_contacts":238,"overall_officials":247,"references":252,"see_also_links":263},"NCT06188585","MDT23013","Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding","Randomized Controlled Multi-Center Non-Inferiority Trial of UI-EWD (Nexpowder™) vs. Conventional Treatment as First-Line Endoscopic Therapy for Patients With High-Risk Nonvariceal Upper Gastrointestinal Bleeding (TREET)","RECRUITING","2029-09","2026-06","2026-06-22","2024-06-21","Medtronic - MITG","INDUSTRY",true,"A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute overt gastrointestinal bleeding which is found at endoscopy to be due to one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear.","Endoscopic hemostatic therapy is recommended as the first line therapy for patients with upper gastrointestinal bleeding (UGIB) due to ulcers with active bleeding or a non-bleeding visible vessel identified at endoscopy. A variety of endoscopic modalities are used in the treatment of UGIB, including thermal therapies (e.g., bipolar electrocoagulation), injection therapy (e.g., epinephrine), clips, and hemostatic powder spray. Topical therapies, such as hemostatic powder spray, have been the most recent addition to the armamentarium of endoscopic therapies for UGIB.\n\nUI-EWD hemostatic powder (Nexpowder™), which is manufactured by NextBiomedical and distributed by Medtronic, is approved for treatment of nonvariceal GI bleeding in the U.S., Canada, European Union and other countries.\n\nA retrospective study of UI-EWD hemostatic powder in 56 patients with active bleeding found immediate hemostasis in 54 (96.4%), with rebleeding within 7 days in only 2 patients (3.7%)\\[1\\]. A large multi-center randomized trial in 340 patients with nonvariceal UGIB and either active bleeding or a non-bleeding visible vessel compared conventional endoscopic hemostatic therapy alone to conventional therapy plus UI-EWD. Rebleeding was significantly lower in the UI-EWD group at 3 days (3 vs. 11%) and at 30 days (19% vs. 7%) \\[2\\].\n\nThe primary aim of this trial is to demonstrate that UI-EWD when used as initial hemostatic therapy is non-inferior to older conventional endoscopic hemostatic therapy for the treatment of patients with high-risk nonvariceal upper GI bleeding.",[19],"Acute Gastrointestinal Bleeding",[21,22,23],"Gastrointestinal hemorrhage","Peptic Ulcer","Nonvariceal upper gastrointestinal bleeding","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},278,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DEVICE","UI-EWD","Hemostatic powder administered at index endoscopy",[37],"Test Group",[39],"Nexpowder™",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Conventional therapy","Conventional endoscopic therapy (bipolar electrocoagulation or clips or argon plasma coagulation, with or without epinephrine injection) administered at index endoscopy",[44],"Control Group",[46,47,48,49],"Bipolar electrocoagulation or Bipolar electrocoagulation endoscopic hemostasis","Epinephrine (1:10,000 dilution) injection or Endoscopic hemostatic injection of epinephrine (1:10,000 dilution)","Endoscopic hemostatic clip","Argon plasma coagulation",[51],{"measure":52,"description":53,"timeFrame":54},"No further bleeding during the 7-day period after hemostatic treatment","Further bleeding includes patients with persistent bleeding despite study-assigned endoscopic therapy or patients with recurrent bleeding","7 days",[56,60,64,67],{"measure":57,"description":58,"timeFrame":59},"Composite 30-day outcome of further bleeding","Further bleeding leading to red blood cell transfusion or urgent intervention (need for alternative therapy at index endoscopy, repeat endoscopy, interventional radiology, or surgery)","30 days",{"measure":61,"description":62,"timeFrame":63},"Initial hemostasis for patients with active bleeding at randomization","Initial hemostasis with study-assigned endoscopic therapy for patients with active bleeding","During index endoscopy procedure",{"measure":65,"description":66,"timeFrame":54},"Number of participants with recurrent bleeding over the 7-day period after randomization","Recurrent bleeding among all patients with hemostasis within 7 days after study-assigned endoscopic therapy",{"measure":68,"description":69,"timeFrame":59},"Mortality","30-day mortality","ALL","22 Years",null,false,{"inclusion":75,"exclusion":76,"raw_text":77},[],[],"Inclusion Criteria:\n\n1. Adults age 22 years or older\n2. Presentation with acute overt gastrointestinal bleeding (hematemesis, melena, and\u002For hematochezia)\n3. Subject voluntarily agrees to participate in the clinical investigation, provides written informed consent, and will be able to comply with the investigational protocol in the opinion of the site investigator\n4. Cause of bleeding as determined at upper endoscopy is one of the following sources: a gastric or duodenal ulcer with active bleeding (spurting or oozing) or a non-bleeding visible vessel; an esophageal, gastric or duodenal tumor with active bleeding or a non-bleeding visible vessel; a gastric or duodenal Dieulafoy lesion with active bleeding or a non-bleeding visible vessel; or an actively bleeding Mallory-Weiss tear. The definition of \"active oozing\" will require bleeding to persist for ≥ 3 minutes of endoscopic observation.\n\nExclusion Criteria:\n\n1. Incarceration\n2. Subjects that are not able to provide written informed consent\n3. Pregnancy or nursing mothers\n4. Endoscopic hemostatic treatment in the past 30 days\n5. Use of triple antithrombotic therapy at the time of presentation\n6. Subjects who underwent gastric or duodenal endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) procedures within the past 2 months\n7. Post-polypectomy bleeding\n8. Subjects with erosive esophagitis, erosive gastritis, esophageal ulcer, or vascular ectasia including gastric antral vascular ectasia\n9. Platelet count \\\u003C 50 x 10\\^9\u002FL\n10. INR \\> 3.5 (or prothrombin time \\>35 seconds in patient not on warfarin and only prothrombin time is provided by local lab), at time of procedure or closest to procedure time\n11. Subjects who have documented galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n12. Subjects with documented hypersensitivity to Brilliant Blue FCF\n13. Subjects with suspected bowel obstruction or gastrointestinal fistulas, and those suspected or are at high risk of having gastrointestinal perforation.\n14. Endoscopy not performed within 36 hours of presentation to hospital\u002Femergency department",[79,80],"ADULT","OLDER_ADULT",[82,97,109,121,133,145,155,167,176,185,196,205,216,227],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Yale","New Haven","Connecticut","06520","United States",[89,92],{"name":90,"role":91},"Kenneth Hung, M.D.","CONTACT",{"name":90,"role":93},"PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},41.30815,-72.92816,{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":87,"contacts":102,"geoPoint":106},"RUSH University","Chicago","Illinois","60612",[103,105],{"name":104,"role":91},"Neal Mehta, M.D.",{"name":104,"role":93},{"lat":107,"lon":108},41.85003,-87.65005,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":87,"contacts":114,"geoPoint":118},"Brigham and Women's Hospital","Boston","Massachusetts","02115",[115,117],{"name":116,"role":91},"Linda Lee, MD",{"name":116,"role":93},{"lat":119,"lon":120},42.35843,-71.05977,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":87,"contacts":126,"geoPoint":130},"Rutgers University","Piscataway","New Jersey","08901",[127,129],{"name":128,"role":91},"Arvind Trindade, M.D.",{"name":128,"role":93},{"lat":131,"lon":132},40.49927,-74.39904,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":87,"contacts":138,"geoPoint":142},"Northwell Health","Manhasset","New York","11030",[139,141],{"name":140,"role":91},"Juan Bucobo, M.D.",{"name":140,"role":93},{"lat":143,"lon":144},40.79788,-73.69957,{"facility":146,"status":8,"city":136,"state":136,"zip":147,"country":87,"contacts":148,"geoPoint":152},"NYU Langone","10016",[149,151],{"name":150,"role":91},"Melissa Debordeaux, M.D.",{"name":150,"role":93},{"lat":153,"lon":154},40.71427,-74.00597,{"facility":156,"status":8,"city":157,"state":158,"country":159,"contacts":160,"geoPoint":164},"McGill University","Montreal","Quebec","Canada",[161,163],{"name":162,"role":91},"Yen-I Chen, M.D.",{"name":162,"role":93},{"lat":165,"lon":166},45.50884,-73.58781,{"facility":168,"status":8,"city":169,"country":159,"contacts":170,"geoPoint":173},"St. Michael's Hospital","Toronto",[171],{"name":172,"role":93},"Jeffrey Mosko, MD, MSc, FRCPC",{"lat":174,"lon":175},43.70643,-79.39864,{"facility":177,"status":8,"city":178,"country":159,"contacts":179,"geoPoint":182},"Vancouver General Hospital","Vancouver",[180],{"name":181,"role":93},"Roberto Trasolini, MD",{"lat":183,"lon":184},49.24966,-123.11934,{"facility":186,"status":8,"city":187,"country":188,"contacts":189,"geoPoint":193},"Copenhagen University Hospital","Hvidovre","Denmark",[190,192],{"name":191,"role":91},"John G Karstensen",{"name":191,"role":93},{"lat":194,"lon":195},55.64297,12.47708,{"facility":197,"status":8,"city":198,"country":188,"contacts":199,"geoPoint":202},"Odense University Hospital","Odense",[200],{"name":201,"role":93},"Stig Laursen, MD, PhD",{"lat":203,"lon":204},55.39594,10.38831,{"facility":206,"status":8,"city":207,"country":208,"contacts":209,"geoPoint":213},"St. Antoine","Paris","France",[210,212],{"name":211,"role":91},"Marine Camus, M.D.",{"name":211,"role":93},{"lat":214,"lon":215},48.85341,2.3488,{"facility":217,"status":8,"city":218,"country":219,"contacts":220,"geoPoint":224},"Emek Medical Center","Afula","Israel",[221,223],{"name":222,"role":91},"Halim Awadie",{"name":222,"role":93},{"lat":225,"lon":226},32.60907,35.2892,{"facility":228,"status":8,"city":229,"country":230,"contacts":231,"geoPoint":235},"Cleveland Clinic London","London","United Kingdom",[232,234],{"name":233,"role":91},"Rehan Haidry, M.D.",{"name":233,"role":93},{"lat":236,"lon":237},51.50853,-0.12574,[239,243],{"name":240,"role":91,"phone":241,"email":242},"Geraldine Kelly","+353014393000","geraldine.kelly@medtronic.com",{"name":244,"role":91,"phone":245,"email":246},"Kara Saddoris","303-476-7598","kara.l.saddoris@medtronic.com",[248],{"name":249,"affiliation":250,"role":251},"Loren Laine, MD","Yale University","STUDY_CHAIR",[253,257,259],{"pmid":254,"type":255,"citation":256},"31828214","BACKGROUND","Park JS, Kim HK, Shin YW, Kwon KS, Lee DH. Novel hemostatic adhesive powder for nonvariceal upper gastrointestinal bleeding. Endosc Int Open. 2019 Dec;7(12):E1763-E1767. doi: 10.1055\u002Fa-0982-3194. Epub 2019 Dec 10.",{"type":255,"citation":258},"Cha B. A Randomized Control Study Evaluating the Efficacy of a Hemostatic Powder (UI-EWD) in Decreasing the Rate of Upper Gastrointestinal Re-Bleeding in Patients Treated with Endoscopic Therapy for High-Risk Lesions. Oral presentation presented at: Digestive Disease Week 2023; May 9, 2023; Chicago, IL.",{"pmid":260,"type":261,"citation":262},"40570926","DERIVED","Al Alawi S, Bessissow T, Fallone CA, Jacques J, Barkun A. Hemostatic powder's battle against a spurting bleeding ulcer: can it win? Endoscopy. 2025 Dec;57(S 01):E676-E677. doi: 10.1055\u002Fa-2610-3096. Epub 2025 Jun 26. No abstract available.",[],{"nct_id":4,"conditions":265,"biomarkers":268},[266,267,22],"Gastrointestinal Hemorrhage","Mallory-Weiss Syndrome",[],{"nct_id":4,"found":15,"summary":270,"prompt_version":280},{"design":271,"status":272,"heading":273,"summary":274,"follow_up":275,"word_count":276,"commitments":277,"compensation":278,"drugs_mentioned":279},"This is a randomized controlled trial, meaning participants will be assigned by chance to receive either UI-EWD or conventional therapy. The study plans to enroll 278 participants.","completed","Study of UI-EWD (Nexpowder™) for Upper Gastrointestinal Bleeding","This study is comparing a new treatment, UI-EWD (Nexpowder™) hemostatic powder, to standard treatments for acute upper gastrointestinal bleeding. This type of bleeding can cause symptoms like vomiting blood (hematemesis) or dark, tarry stools (melena). Researchers want to see if UI-EWD is as effective as conventional methods like electrocautery or clips in stopping bleeding. You may be able to join if you are an adult aged 22 or older and have acute gastrointestinal bleeding from specific sources like ulcers or tumors. The main goal is to see if bleeding stops and doesn't restart within 7 days after treatment. The study aims to enroll 278 participants, but its current status is unclear.","The primary endpoint is measured at 7 days, looking for no further bleeding during that period after treatment.",111,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]