[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06612281":3,"trial-entities:NCT06612281":98,"trial-summary:NCT06612281":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":49,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":14,"eligibility_criteria":61,"std_ages":68,"locations":71,"central_contacts":87,"overall_officials":92,"references":93,"see_also_links":94},"NCT06612281","CL-1015","Evaluation of Gixam's Performance in a FIT Negative Population","RECRUITING","2025-04-30","2024-11","2024-11-14","2024-11-01","Jubaan Ltd.","INDUSTRY",false,"In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.\n\nThe device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.\n\nThe purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.",null,[18,19,20],"Colorectal Adenoma","Colorectal Cancer (CRC)","Colorectal Cancer (CRC) Screening",[22,23,24],"Microbiome","Spectral signature","Artificial intelligence","INTERVENTIONAL","SCREENING",[28],"PHASE2",{"count":30,"type":31},400,"ESTIMATED",[33,39,44],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","colorectal cancer (CRC) screening","Gixam test",[38],"Single arm",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DIAGNOSTIC_TEST","colorectal cancer screening","Fecal Immunochemistry Test (FIT)",[38],{"type":45,"name":46,"description":47,"armGroupLabels":48},"PROCEDURE","Colonoscopy after bowel cleansing","Standard of care optical colonoscopy for colorectal cancer screening",[38],[50,54],{"measure":51,"description":52,"timeFrame":53},"Safety - number of device related adverse events and serious adverse events","Number of device related adverse events and serious adverse events","Through study completion, up to 30 days",{"measure":55,"description":56,"timeFrame":53},"Efficacy - Gixam's sensitivity and specificity","Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) \u002F CRC in a FIT negative population.",[],"ALL","45 Years","85 Years",{"inclusion":62,"exclusion":63,"raw_text":67},[],[64,65,66],"Familial adenomatous polyposis (also referred to as \\"FAP\\", including attenuated FAP and Gardner\\'s syndrome),","Hereditary non-polyposis CRC syndrome (also referred to as \\"HNPCC\\" or \\"Lynch Syndrome\\"),","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. 6. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and\u002For Crohn\\'s disease. 7. Subjects with a disability to extend their tongue. 8. Subjects with tongue piercing. 9. Dental visit in the past 7 days prior to Gixam test. 10. Intake of pro-biotics over the past 3 months pre-Gixam test. 11. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.","Inclusion Criteria:\n\n1. Subjects aged 45-85 years.\n2. Able to provide a signed informed consent.\n3. Scheduled for a screening colonoscopy at the investigation site.\n\nExclusion Criteria:\n\n1. Undergoing diagnostic colonoscopy for investigation of symptoms.\n2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.\n3. History of colorectal cancer.\n4. Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.\n5. 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.\n6. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and\u002For Crohn\\'s disease.\n7. Subjects with a disability to extend their tongue.\n8. Subjects with tongue piercing.\n9. Dental visit in the past 7 days prior to Gixam test.\n10. Intake of pro-biotics over the past 3 months pre-Gixam test.\n11. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":7,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"The Oregon Clinic Gastroenterology-East","Portland","Oregon","97220","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Diane Snelson","CONTACT","503-963-2782","dsnelson@orclinic.com",{"lat":85,"lon":86},45.52345,-122.67621,[88],{"name":89,"role":81,"phone":90,"email":91},"Daniella Bleistein","+972549599353","daniella@jubaan.com",[],[],[95],{"label":96,"url":97},"Related Info","https:\u002F\u002Fjubaan.com\u002F",{"nct_id":4,"conditions":99,"biomarkers":101},[18,100],"Colorectal Carcinoma",[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This interventional study plans to enroll about 400 participants. It is evaluating the Gixam test and a standard colonoscopy for colorectal cancer screening.","completed","Evaluating Gixam for Colorectal Cancer Screening","This study is evaluating a new device called Gixam for colorectal cancer (CRC) screening. Gixam is a camera that takes pictures of your tongue and uses artificial intelligence to predict if you have precancerous polyps in your colon or rectum. These polyps can eventually turn into cancer. The study aims to see how well Gixam works (its sensitivity and specificity) and if it is safe. You might be able to join if you are between 45 and 85 years old, are scheduled for a screening colonoscopy (a procedure to look inside your colon), and have had a negative Fecal Immunochemistry Test (FIT), which checks for blood in your stool. The study is currently unclear on its recruitment status and plans to enroll about 400 people.","Participants will be followed through study completion, up to 30 days, to measure safety and efficacy.",125,"You would undergo the Gixam test, a Fecal Immunochemistry Test (FIT), and a colonoscopy after bowel cleansing. The study will measure safety and effectiveness through study completion, up to 30 days.","Not stated in the trial record.",[35],"v2"]