[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jubaan Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637188","evaluation-of-gixams-efficacy-predicting-the-presence-of-advanced-and-non-advanced-colorectal-neoplasia-in-a-fit-negative-population-100637188",false,"NCT07623902","Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population","Inclusion Criteria:\n\n1. Participants aged ≥45 - ≤84 years.\n2. Able to provide a signed informed consent.\n3. Considered by a physician or healthcare provider as being of 'average risk' for CRC.\n4. Scheduled for a screening colonoscopy at investigation site.\n\nExclusion Criteria:\n\n1. Undergoing 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. Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.\n4. Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.\n5. History of colorectal cancer.\n6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.\n7. Participant 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 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.\n8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and\u002For Crohn's disease.\n9. Participants with a disability to extend their tongue.\n10. Participants with tongue tremor.\n11. Participants with tongue piercing.\n12. Participants that had a dental visit in the 7 days prior to the Gixam test.\n13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.\n14. Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.\n15. Participant is pregnant.\n16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.","ALL","45 Years","84 Years",{"count":19,"type":20},1436,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are:\n\n1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result?\n2. Is the use of the Gixam device safe?\n\nGixam test result will be compared to the findings of a standard of care screening colonoscopy.\n\nStudy participants will:\n\n1. Undergo the Gixam test\n2. Take a FIT at home and ship to a laboratory.\n3. Undergo a standard of care screening colonoscopy.",[26,27],"CRC Screening","Microbiome","RECRUITING","2026-05-28",{"date":31,"type":32},"2026-06-03","ACTUAL",{"date":34,"type":32},"2026-05-18",{"date":36,"type":20},"2026-12-31",{"name":38,"class":39},"Jubaan Ltd.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100568966","evaluation-of-gixams-efficacy-predicting-pre-cancerous-colorectal-polyps-and-colorectal-cancer-100568966","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.","50 Years","80 Years",{"count":50,"type":20},800,[23],"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.",[54,55,56],"Colorectal Cancer","Colorectal Adenomatous Polyp","Colorectal Neoplasms","NOT_YET_RECRUITING","2024-11-13",{"date":60,"type":32},"2024-11-14",{"date":62,"type":20},"2025-02",{"date":64,"type":20},"2026-04",{"name":38,"class":39},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":66},"100563139","phase-2-evaluation-of-gixams-performance-in-a-fit-negative-population-100563139","NCT06612281","Evaluation of Gixam's Performance in a FIT Negative Population","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.","85 Years",{"count":75,"type":20},400,[77],"PHASE2","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.",[80,81,82],"Colorectal Adenoma","Colorectal Cancer (CRC)","Colorectal Cancer (CRC) Screening",[27,84,85],"Spectral signature","Artificial intelligence","2024-11-12",{"date":60,"type":32},{"date":89,"type":32},"2024-11-01",{"date":91,"type":20},"2025-04-30",{"name":38,"class":39},""]