[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497169":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":37,"locations":47,"responsibleParty":435,"collaborators":437,"id":444,"slug":445,"hasResults":446,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":446,"sex":452,"minAge":453,"maxAge":454,"enrollmentInfo":455,"targetDuration":12,"studyType":458,"phases":459,"briefSummary":461,"conditions":462,"keywords":466,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":477},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic Surveillance","NO_INTERVENTION","Subjects in the randomized control trial and observational cohort study, undergoing surveillance endoscopy will undergo surveillance biopsies in a 4-quadrant fashion every 1 cm throughout the extent of the Barrett's esophagus using the Seattle biopsy protocol, along with targeted biopsies from any visible lesions. For incident low grade dysplasia (newly diagnosed low grade dysplasia - within 12 months of enrollment), surveillance endoscopies will be performed every 6 months for the first year and then annually until the end of the study period. For prevalent low grade dysplasia (diagnosed \\>1 year prior to enrollment), surveillance endoscopies will be performed annually until the end of the study period. The number of evaluations will depend on a subject's enrollment time.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Endoscopic Eradication Therapy","EXPERIMENTAL","Subjects undergoing endoscopic eradication therapy will undergo radiofrequency ablation every 2-3 months until complete eradication of intestinal metaplasia (CE-IM) is achieved or 5 treatments have been delivered, whichever is first. After achieving CE-IM, surveillance endoscopy will performed every 6 months for the first year and annually thereafter until the end of the study period. Surveillance biopsies will be obtained using a standardized protocol.",[18],"Procedure: Endoscopic Eradication Therapy",[20],{"type":21,"name":14,"description":22,"armGroupLabels":23,"otherNames":12},"PROCEDURE","Endoscopic eradication therapy is a procedure performed to destroy the precancerous cells at the bottom of your esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures are performed through the endoscope.",[14],[25,28,31,34],{"name":26,"affiliation":5,"role":27},"Sachin Wani, MD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Nicholas J Shaheen, MD, MPH","University of North Carolina",{"name":32,"affiliation":33,"role":27},"Valerie Durkalski, MPH, PhD","Medical University of South Carolina",{"name":35,"affiliation":36,"role":27},"Rhonda Souza, MD","Baylor University",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},"Jillian Welker","CONTACT","2489127809","jwelker89@gmail.com",{"name":44,"role":40,"phone":45,"phoneExt":12,"email":46},"Sandra Boimbo","303-724-8892","sandra.boimbo@cuanschutz.edu",[48,69,83,98,111,128,145,160,177,192,209,226,247,264,283,299,316,333,350,367,384,400,420],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of California, Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-118.24368,34.05223,{"lat":60,"lon":59},[63,67],{"name":64,"role":40,"phone":65,"phoneExt":12,"email":66},"Nazish Zafar","310-206-6710","nzafar@mednet.ucla.edu",{"name":68,"role":27,"phone":12,"phoneExt":12,"email":12},"V. Raman Muthusamy, MD",{"facility":70,"status":50,"city":71,"state":52,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Kaiser Permanente Oakland Medical Center","Oakland","94611",{"type":57,"coordinates":74},[75,76],-122.2708,37.80437,{"lat":76,"lon":75},[79],{"name":80,"role":40,"phone":81,"phoneExt":12,"email":82},"Gene K Ma, MD","408-972-6530","gene.k.ma@kp.org",{"facility":84,"status":50,"city":85,"state":52,"zip":86,"country":54,"countryCode":55,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Kaiser Permanente","San Jose","95119",{"type":57,"coordinates":88},[89,90],-121.89496,37.33939,{"lat":90,"lon":89},[93,96],{"name":94,"role":40,"phone":81,"phoneExt":12,"email":95},"Victoria Peckham","victoria.k.peckham@kp.org",{"name":97,"role":27,"phone":12,"phoneExt":12,"email":12},"Gene Ma, MD",{"facility":99,"status":50,"city":100,"state":101,"zip":102,"country":54,"countryCode":55,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"University of Colorado","Aurora","Colorado","80045",{"type":57,"coordinates":104},[105,106],-104.83192,39.72943,{"lat":106,"lon":105},[109],{"name":44,"role":40,"phone":110,"phoneExt":12,"email":46},"3037248892",{"facility":112,"status":50,"city":113,"state":114,"zip":115,"country":54,"countryCode":55,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Florida Digestive Health Specialists","Sarasota","Florida","34239",{"type":57,"coordinates":117},[118,119],-82.53065,27.33643,{"lat":119,"lon":118},[122,126],{"name":123,"role":40,"phone":124,"phoneExt":12,"email":125},"Jennifer Faircloth","941-952-1145","jfaircloth@suncoastendoscopy.com",{"name":127,"role":27,"phone":12,"phoneExt":12,"email":12},"F. Scott Corbett, MD, FASGE",{"facility":129,"status":50,"city":130,"state":131,"zip":132,"country":54,"countryCode":55,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Northwestern Memorial Hospital","Chicago","Illinois","60611",{"type":57,"coordinates":134},[135,136],-87.65005,41.85003,{"lat":136,"lon":135},[139,143],{"name":140,"role":40,"phone":141,"phoneExt":12,"email":142},"Justeena Jojo","312-695-5620","justeena.jojo@northwestern.edu",{"name":144,"role":27,"phone":12,"phoneExt":12,"email":12},"Srinadh Komanduri, MD",{"facility":146,"status":50,"city":147,"state":148,"zip":149,"country":54,"countryCode":55,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Indiana University Melvin & Bren Simon Cancer Center","Indianapolis","Indiana","46202",{"type":57,"coordinates":151},[152,153],-86.15804,39.76838,{"lat":153,"lon":152},[156],{"name":157,"role":40,"phone":158,"phoneExt":12,"email":159},"Mohammad Al-Hadded, MD","317-278-9242","moalhadd@iu.edu",{"facility":161,"status":50,"city":162,"state":163,"zip":164,"country":54,"countryCode":55,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Johns Hopkins Universtiy","Baltimore","Maryland","21205",{"type":57,"coordinates":166},[167,168],-76.61219,39.29038,{"lat":168,"lon":167},[171,175],{"name":172,"role":40,"phone":173,"phoneExt":12,"email":174},"Hilary Cosby","410-502-2893","hcosby1@jhmi.edu",{"name":176,"role":27,"phone":12,"phoneExt":12,"email":12},"Macia Canto, MD",{"facility":178,"status":50,"city":179,"state":180,"zip":181,"country":54,"countryCode":55,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":57,"coordinates":183},[184,185],-71.05977,42.35843,{"lat":185,"lon":184},[188],{"name":189,"role":40,"phone":190,"phoneExt":12,"email":191},"Douglas Pleskow, MD","617-632-8623","dpleskow@bidmc.harvard.edu",{"facility":193,"status":50,"city":194,"state":195,"zip":196,"country":54,"countryCode":55,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"University of Michigan","Ann Arbor","Michigan","48109",{"type":57,"coordinates":198},[199,200],-83.74088,42.27756,{"lat":200,"lon":199},[203,207],{"name":204,"role":40,"phone":205,"phoneExt":12,"email":206},"Jaren Fehlman","734-845-5865","jfehlman@med.umich.edu",{"name":208,"role":27,"phone":12,"phoneExt":12,"email":12},"Joel Rubenstein, MD",{"facility":210,"status":50,"city":211,"state":212,"zip":213,"country":54,"countryCode":55,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Washington University in St. Louis","St Louis","Missouri","63110",{"type":57,"coordinates":215},[216,217],-90.19789,38.62727,{"lat":217,"lon":216},[220,224],{"name":221,"role":40,"phone":222,"phoneExt":12,"email":223},"Thomas Hollander","314-747-1973","hollanderT@wustl.edu",{"name":225,"role":27,"phone":12,"phoneExt":12,"email":12},"Vladimir Kushnir, MD",{"facility":227,"status":50,"city":228,"state":229,"zip":230,"country":54,"countryCode":55,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Dartmouth-Hitchcock Medical Center","Lebanon","New Hampshire","03756",{"type":57,"coordinates":232},[233,234],-72.25176,43.64229,{"lat":234,"lon":233},[237,241,245],{"name":238,"role":40,"phone":239,"phoneExt":12,"email":240},"Penny Doughty","603-695-2840","penny.j.doughty@hitchcock.org",{"name":242,"role":40,"phone":243,"phoneExt":12,"email":244},"Diane Rivera","000-000-0000","diane.rivera@va.gov",{"name":246,"role":27,"phone":12,"phoneExt":12,"email":12},"Heiko Pohl, MD",{"facility":248,"status":50,"city":249,"state":250,"zip":251,"country":54,"countryCode":55,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Long Island Jewish Medical Center","Manhasset","New York","11030",{"type":57,"coordinates":253},[254,255],-73.69957,40.79788,{"lat":255,"lon":254},[258,262],{"name":259,"role":40,"phone":260,"phoneExt":12,"email":261},"Molly Stewart","718-470-4667","mstewart8@northwell.edu",{"name":263,"role":27,"phone":12,"phoneExt":12,"email":12},"Arvind Trindade, MD, FASGE",{"facility":265,"status":50,"city":250,"state":250,"zip":266,"country":54,"countryCode":55,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Columbia Universtiy","10032",{"type":57,"coordinates":268},[269,270],-74.00597,40.71427,{"lat":270,"lon":269},[273,277,281],{"name":274,"role":40,"phone":275,"phoneExt":12,"email":276},"Kartharine D Boyce","212-305-9542","KB3217@cumc.columbia.edu",{"name":278,"role":40,"phone":279,"phoneExt":12,"email":280},"Rowena Fang","212-305-9541","RF2808@cumc.columbia.edu",{"name":282,"role":27,"phone":12,"phoneExt":12,"email":12},"Julian Abrams, MD",{"facility":284,"status":50,"city":285,"state":250,"zip":286,"country":54,"countryCode":55,"cosmosGeoPoint":287,"geoPoint":291,"contacts":292},"University of Rochester Medical Center","Rochester","14642",{"type":57,"coordinates":288},[289,290],-77.61556,43.15478,{"lat":290,"lon":289},[293,297],{"name":294,"role":40,"phone":295,"phoneExt":12,"email":296},"Chelsea Dibella","(585)-275-0803","Chelsea_dibella@urmc.rochester.edu",{"name":298,"role":27,"phone":12,"phoneExt":12,"email":12},"Vivek Kaul, MD",{"facility":300,"status":50,"city":301,"state":302,"zip":303,"country":54,"countryCode":55,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"University of North Carolina School of Medicine","Chapel Hill","North Carolina","27599",{"type":57,"coordinates":305},[306,307],-79.05584,35.9132,{"lat":307,"lon":306},[310,314],{"name":311,"role":40,"phone":312,"phoneExt":12,"email":313},"Julia Kim","919-843-3946","Julia_Kim@med.unc.edu",{"name":315,"role":27,"phone":12,"phoneExt":12,"email":12},"Nicholas Shaheen, MD, MPH",{"facility":317,"status":50,"city":318,"state":319,"zip":320,"country":54,"countryCode":55,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"University Hospitals Cleveland Medical Center Case Western University","Cleveland","Ohio","44106",{"type":57,"coordinates":322},[323,324],-81.69541,41.4995,{"lat":324,"lon":323},[327,331],{"name":328,"role":40,"phone":329,"phoneExt":12,"email":330},"Wendy Brock","206-844-3853","wendy.brock@uhhospitals.org",{"name":332,"role":27,"phone":12,"phoneExt":12,"email":12},"Amitabh Chak, MD",{"facility":334,"status":50,"city":318,"state":319,"zip":335,"country":54,"countryCode":55,"cosmosGeoPoint":336,"geoPoint":338,"contacts":339},"Cleveland Clinic Foundation","44195",{"type":57,"coordinates":337},[323,324],{"lat":324,"lon":323},[340,344,348],{"name":341,"role":40,"phone":342,"phoneExt":12,"email":343},"Vidhi Patel","216-363-5555","pdatelv18@ccf.org",{"name":345,"role":40,"phone":346,"phoneExt":12,"email":347},"Kevin Kruszewski","216-636-5555","kruszek@ccf.org",{"name":349,"role":27,"phone":12,"phoneExt":12,"email":12},"Prashanthi Thota, MD",{"facility":351,"status":50,"city":352,"state":353,"zip":354,"country":54,"countryCode":55,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"University of Pennsylania, Perelman School of Medicine","Philadelphia","Pennsylvania","19104",{"type":57,"coordinates":356},[357,358],-75.16362,39.95238,{"lat":358,"lon":357},[361,365],{"name":362,"role":40,"phone":363,"phoneExt":12,"email":364},"Christine Gepty, BSN, RN","215-349-8556","christine.gepty@pennmedicine.upenn.edu",{"name":366,"role":27,"phone":12,"phoneExt":12,"email":12},"Gary Falk, MD, MS",{"facility":368,"status":50,"city":369,"state":353,"zip":370,"country":54,"countryCode":55,"cosmosGeoPoint":371,"geoPoint":375,"contacts":376},"University of Pittsburgh Medical Center","Pittsburgh","15213",{"type":57,"coordinates":372},[373,374],-79.99589,40.44062,{"lat":374,"lon":373},[377,380,382],{"name":378,"role":40,"phone":12,"phoneExt":12,"email":379},"Adalyn Vincent","AMV116@pitt.edu",{"name":381,"role":27,"phone":12,"phoneExt":12,"email":12},"Kevin Mcgrath",{"name":383,"role":27,"phone":12,"phoneExt":12,"email":12},"Ken Fasanella",{"facility":33,"status":50,"city":385,"state":386,"zip":387,"country":54,"countryCode":55,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"Charleston","South Carolina","29425",{"type":57,"coordinates":389},[390,391],-79.93275,32.77632,{"lat":391,"lon":390},[394,398],{"name":395,"role":40,"phone":396,"phoneExt":12,"email":397},"Collins Ordiah, MD","943-876-1648","ordiah@cusc.edu",{"name":399,"role":27,"phone":12,"phoneExt":12,"email":12},"B Joseph Elmunzer, MD",{"facility":401,"status":50,"city":402,"state":403,"zip":404,"country":54,"countryCode":55,"cosmosGeoPoint":405,"geoPoint":409,"contacts":410},"Baylor University Medical Center","Dallas","Texas","75246",{"type":57,"coordinates":406},[407,408],-96.80667,32.78306,{"lat":408,"lon":407},[411,415,418],{"name":412,"role":40,"phone":413,"phoneExt":12,"email":414},"Taryn Kruse","469-800-7050","taryn.kruse@bswhealth.org",{"name":416,"role":40,"phone":413,"phoneExt":12,"email":417},"Daniel S Kim","daniel.kim3@bswhealth.org",{"name":419,"role":27,"phone":12,"phoneExt":12,"email":12},"Vani Konda, MD",{"facility":421,"status":50,"city":422,"state":403,"zip":423,"country":54,"countryCode":55,"cosmosGeoPoint":424,"geoPoint":428,"contacts":429},"The University of Texas MD Anderson Cancer Center","Houston","77030",{"type":57,"coordinates":425},[426,427],-95.36327,29.76328,{"lat":427,"lon":426},[430,433],{"name":431,"role":40,"phone":12,"phoneExt":12,"email":432},"Raza Bokhari","rhbokhari@mdanderson.org",{"name":434,"role":27,"phone":12,"phoneExt":12,"email":12},"Mehnaz Shafi",{"type":436,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[438,439,440,441],{"name":36,"class":6},{"name":30,"class":6},{"name":33,"class":6},{"name":442,"class":443},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100497169","surveillance-vs-endoscopic-therapy-for-barretts-esophagus-with-low-grade-dysplasia-100497169",false,"NCT05753748","Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia","A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus With Low-grade Dysplasia (The SURVENT Trial)","SURVENT","Inclusion Criteria: Any patient with Barrett's esophagus and low grade dysplasia who provides informed consent AND:\n\nMeets all the following criteria will be eligible for enrollment:\n\n1. Male or female, age ≥18 years,\n2. Subject has endoscopic evidence of Barrett's esophagus characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia,\n3. Biopsies within the previous 12 months demonstrating Barrett's esophagus and low grade dysplasia,\n4. Confirmation of low grade dysplasia by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician),\n5. Demonstrated ability to tolerate proton pump inhibitor (PPI) therapy based on patient self-report, and, Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.\n\nExclusion Criteria:\n\n1. Pregnancy;\n2. Prior endoscopic eradication therapy for Barrett's esophagus;\n3. History of high grade dysplasia or post-endoscopy esophageal adenocarcinoma;\n4. History of esophageal resection\u002Fesophagectomy\n5. Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis;\n6. Esophageal strictures precluding passage of the endoscope or treatment catheters - patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy;\n7. Esophageal varices or known portal hypertension; and\n8. Life expectancy of \\\u003C2 years as judged by the site investigator. \\* Presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion. Subjects with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology; those with high grade dysplasia or post-endoscopy esophageal adenocarcinoma pathology will exit the study after a 30-day safety follow up.","ALL","18 Years","89 Years",{"count":456,"type":457},680,"ESTIMATED","INTERVENTIONAL",[460],"NA","The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy.\n\nTo diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.\n\nEndoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments.\n\nWhile both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other.\n\nBarrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and\u002For cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia.\n\nThis is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.",[463,464,465],"Barretts Esophagus With Dysplasia","Barrett Esophagus","Esophageal Adenocarcinoma",[464,465,467],"Dysplasia","2025-11-18",{"date":470,"type":471},"2025-11-24","ACTUAL",{"date":473,"type":471},"2023-01-24",{"date":475,"type":457},"2029-04-30",{"name":5,"class":6},23]