[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568966":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":22,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":22,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":22,"overallStatus":70,"whyStopped":22,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Jubaan Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gixam followed by standard of care colonoscopy","EXPERIMENTAL","All enrolled participants will undergo the Gixam test followed by a standard of care colonoscopy",[13],"Device: Gixam System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Gixam System","Jubaan's Gixam System is designed to predict the likelihood of colorectal adenomas or SSL by using white light in the 400 to 720 nm range to capture ultra-high-definition images of the of the tongue and analyzing the spectral signature of the oral microbiome to predict the presence of colorectal adenomas or SSL with help of artificial intelligence (AI).",[9],[21],"Colonoscopy",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Daniella Bleistein","CONTACT","+972549599353","daniella@jubaan.com",[30],{"facility":31,"status":22,"city":32,"state":22,"zip":22,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Erasmus MC","Rotterdam","Netherlands","NL",{"type":36,"coordinates":37},"Point",[38,39],4.47917,51.9225,{"lat":39,"lon":38},[42],{"name":43,"role":26,"phone":22,"phoneExt":22,"email":22},"Michiel Maas, MD",{"type":45,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[47],{"name":48,"class":49},"Jubaan GmbH","UNKNOWN","100568966","evaluation-of-gixams-efficacy-predicting-pre-cancerous-colorectal-polyps-and-colorectal-cancer-100568966",false,"NCT06688110","Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer","Inclusion Criteria:\n\n1. Subjects aged ≥50 - ≤80 years.\n2. Able to provide a signed informed consent.\n3. Underwent FIT screening within the past 6 months with a positive result.\n4. Scheduled for a FIT positive screening colonoscopy at investigational site.\n\nExclusion Criteria:\n\n1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.\n2. Personal history of CRC.\n3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.\n4. Subject has a diagnosis or medical \u002F family history of any of the following conditions, including:\n\n   * Familial adenomatous polyposis (also referred to as \"FAP\", including attenuated FAP and Gardner's syndrome),\n   * Hereditary non-polyposis CRC syndrome (also referred to as \"HNPCC\" or \"Lynch Syndrome\"),\n   * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.\n5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and\u002For Crohn's disease, and\u002For IBD-undefined.\n6. Subjects with the disability to extend their tongue.\n7. Subjects with tongue piercing.\n8. Dental visit in the 7 days prior to the Gixam test.\n9. Intake of pro-biotics over the past 3 months pre-Gixam test.\n10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.","ALL","50 Years","80 Years",{"count":60,"type":61},800,"ESTIMATED","INTERVENTIONAL",[64],"NA","This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.",[67,68,69],"Colorectal Cancer","Colorectal Adenomatous Polyp","Colorectal Neoplasms","NOT_YET_RECRUITING","2024-11-13",{"date":73,"type":74},"2024-11-14","ACTUAL",{"date":76,"type":61},"2025-02",{"date":78,"type":61},"2026-04",{"name":5,"class":6},1]