[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359582":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":30,"centralContacts":34,"locations":41,"responsibleParty":152,"collaborators":154,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":39,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":39,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":68,"whyStopped":39,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,13,17],{"label":9,"type":6,"description":10,"interventionNames":11},"Screening Population","Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.",[12],"Device: Sponge Capsule",{"label":14,"type":6,"description":15,"interventionNames":16},"Upper endoscopy - Barrett's Esophagus","Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Upper endoscopy - No Barrett's Esophagus","Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.",[12],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Sponge Capsule","Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.",[9,14,18],[28,29],"EsophaCap","Cytosponge",[31],{"name":32,"affiliation":5,"role":33},"Prasad G. Iyer, M.D.","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Clinical Trials Referral Office","CONTACT","855-776-0015",null,"mayocliniccancerstudies@mayo.edu",[42,56,66,84,93,107,117,127,142],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":39},"Mayo Clinic Arizona","COMPLETED","Scottsdale","Arizona","85259","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-111.89903,33.50921,{"lat":54,"lon":53},{"facility":57,"status":44,"city":58,"state":59,"zip":60,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":39},"Mayo Clinic Jacksonville","Jacksonville","Florida","32224",{"type":51,"coordinates":62},[63,64],-81.65565,30.33218,{"lat":64,"lon":63},{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":48,"countryCode":49,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Mayo Clinic Health Systems - Austin","RECRUITING","Austin","Minnesota","55912",{"type":51,"coordinates":73},[74,75],-92.97464,43.66663,{"lat":75,"lon":74},[78,82],{"name":79,"role":37,"phone":80,"phoneExt":39,"email":81},"Ramona Lansing, RN","507-538-4974","lansing.ramona@mayo.edu",{"name":83,"role":33,"phone":39,"phoneExt":39,"email":39},"Eduardo Antpack, MD",{"facility":85,"status":44,"city":86,"state":70,"zip":87,"country":48,"countryCode":49,"cosmosGeoPoint":88,"geoPoint":92,"contacts":39},"Mayo Clinic Health Systems - Mankato","Mankato","56001",{"type":51,"coordinates":89},[90,91],-94.00915,44.15906,{"lat":91,"lon":90},{"facility":94,"status":68,"city":95,"state":70,"zip":96,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Mayo Clinic Rochester","Rochester","55905",{"type":51,"coordinates":98},[99,100],-92.4699,44.02163,{"lat":100,"lon":99},[103,104,106],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":105,"role":37,"phone":80,"phoneExt":39,"email":81},"Ramona Lansing, R.N.",{"name":32,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":108,"status":44,"city":109,"state":110,"zip":111,"country":48,"countryCode":49,"cosmosGeoPoint":112,"geoPoint":116,"contacts":39},"Northwell Health","New Hyde Park","New York","11040",{"type":51,"coordinates":113},[114,115],-73.68791,40.7351,{"lat":115,"lon":114},{"facility":118,"status":44,"city":119,"state":120,"zip":121,"country":48,"countryCode":49,"cosmosGeoPoint":122,"geoPoint":126,"contacts":39},"Baylor Scott & White Research Institute","Dallas","Texas","75246",{"type":51,"coordinates":123},[124,125],-96.80667,32.78306,{"lat":125,"lon":124},{"facility":128,"status":68,"city":129,"state":130,"zip":131,"country":48,"countryCode":49,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Mayo Clinic Health System-Eau Claire","Eau Claire","Wisconsin","54701",{"type":51,"coordinates":133},[134,135],-91.49849,44.81135,{"lat":135,"lon":134},[138],{"name":139,"role":37,"phone":140,"phoneExt":39,"email":141},"Rebecca L. Schmidt, R.N.","715-838-5137","Schmidt.Rebecca2@mayo.edu",{"facility":143,"status":144,"city":145,"state":130,"zip":146,"country":48,"countryCode":49,"cosmosGeoPoint":147,"geoPoint":151,"contacts":39},"Mayo Clinic Health System-Franciscan Healthcare","WITHDRAWN","La Crosse","54601",{"type":51,"coordinates":148},[149,150],-91.23958,43.80136,{"lat":150,"lon":149},{"type":153,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[155],{"name":156,"class":157},"National Cancer Institute (NCI)","NIH","100359582","minimally-invasive-molecular-approaches-for-the-diagnosis-of-barretts-esophagus-and-esophageal-adenocarcinoma-100359582",false,"NCT03961945","Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma","Inclusion Criteria Aim1:\n\n* Male and female ages 50-85\n* Patients who have three or more risk factors for Barrett's Esophagus.\n* Gastroesophageal reflux disease defined by:\n\n  * Diagnosis\n  * Use of one of the following drugs \\>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine\n  * prior endoscopic diagnosis of erosive esophagitis\n* Body mass index (BMI) \\>= 30\n\nExclusion Criteria Aim1 and Aim 3:\n\n* Previous history of:\n\n  * esophageal adenocarcinoma\u002Fcancer\n  * esophageal squamous carcinoma\n  * endoscopic ablation for Barrett's esophagus\n  * esophageal squamous dysplasia\n* Current treatment with oral anticoagulation including Warfarin, Coumadin\n* History of cirrhosis\n* History of esophageal\u002Fgastric varices\n* History of Barrett's esophagus\n* Prior endoscopy in the last 5 years\n\nInclusion criteria Aim 2 and Aim 3:\n\n* Subjects with known or suspected BE (cases).\n\n  * Patient between the ages 18 - 90.\n  * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.\n  * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.\n  * Undergoing clinically indicated endoscopy.\n* Subjects without known history of BE (controls).\n\n  * Undergoing clinically indicated diagnostic endoscopy.\n\nExclusion criteria Aim 2:\n\n* Subjects with known BE.\n\n  * Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)\u002Fendoscopic submucosal dissection (ESD) alone will not be excluded.\n  * Patients with history of esophageal resection for esophageal carcinoma.\n* For subjects with or without known evidence of BE (on history or review of medical records):\n\n  * Pregnant or lactating females.\n  * Patients who are unable to consent.\n  * Patients with current history of uninvestigated dysphagia (this does not apply to the brushings\u002Fbiopsies only portion of the study).\n  * History of eosinophilic esophagitis, achalasia.\n  * Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings\u002Fbiopsies only portion of the study).\n  * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.\n  * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.\n  * Patients with history of known esophageal or gastric varices or cirrhosis.\n  * Patients with history of surgical esophageal resection for esophageal carcinoma.\n  * Patients with congenital or acquired bleeding diatheses.\n  * Patients with a history of esophageal squamous dysplasia.\n  * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.\n  * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.",true,"ALL","18 Years","90 Years",{"count":169,"type":170},1550,"ESTIMATED","INTERVENTIONAL",[173],"NA","This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia\u002Fadenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.",[176,177],"Barrett Esophagus","Esophageal Adenocarcinoma",[179,180,181,182,177],"Barrett's Esophagus","Gastroesophageal Reflux","Reflux","Esophageal Cancer","2026-01-23",{"date":185,"type":186},"2026-01-26","ACTUAL",{"date":188,"type":186},"2021-07-01",{"date":190,"type":170},"2030-07-30",{"name":5,"class":6},9]