[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectalanal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectalanal":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100376703","efficacy-and-safety-of-the-cg-100-intraluminal-bypass-device-100376703",false,"NCT04184973","Efficacy and Safety of the CG-100 Intraluminal Bypass Device","Efficacy and Safety of the CG-100 Intraluminal Bypass Device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized Trial","Inclusion Criteria:\n\n1. The patient is willing to comply with protocol-specified follow-up evaluations\n2. Patient 22-65 years of age at screening, or patient 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.\n3. Patient is diagnosed with colorectal cancer\n4. Patient is scheduled for elective either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis, maximally 10 cm from the anal verge\n5. Patients who are scheduled to receive a protective stoma under routine clinical practice during their primary planned operation.\n6. Patient is scheduled to undergo mechanical bowel preparation\n7. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).\n\nExclusion Criteria:\n\n1. Patient has local or systemic infection at the time of intervention (e.g., peritonitis)\n2. Major surgical or interventional procedures within 45 days prior to this study or planned surgical or interventional procedures within 6 months of entry into this study (not including, placement of port for chemotherapy or ureter stent insertion).\n3. Patients with ASA classification \\> 3\n4. Albumin \\\u003C 30 g\u002Fliter\n5. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease\n6. Patients has a diagnosis of coagulopathy, thrombocytopenia, immune suppression\n7. BMI ≥ 40\n8. Patient is going through another surgical procedure (other than ileostomy, adhesiolysis) during the surgery.\n9. The patient is currently participating in another investigational drug or device study unless pre-approved by the sponsor.\n10. Patient has been taking regular systemic\u002F steroid medication in the last 6 months.\n11. Patients is taking antimetabolites or antiplatelet agents.\n12. Patient has preexisting sphincter problems\n13. Patient has evidence of extensive local disease in the pelvis or has undergone a prior pelvic anastomosis.\n14. Patients with massive diverticulosis at the sigmoid\u002Fdescending colon (viewed on preoperative CT)\n15. Any condition or abnormality which in the opinion of the investigator may jeopardize the patient's safe participation or the quality of the data\n16. Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.","ALL","22 Years","70 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"NA","A randomized trial to assess the safety and efficacy of CG-100 for reducing stoma creation rate in subjects undergoing mesorectal excision.",[27,28,29],"Rectal Cancer","Rectal Tumor","Rectal\u002FAnal",[31,32,33,34,35],"anastomosis","leak","mesorectal","ileostomy","colostomy","RECRUITING","2025-10-21",{"date":39,"type":40},"2025-10-23","ACTUAL",{"date":42,"type":40},"2020-06-23",{"date":44,"type":21},"2026-12-31",{"name":46,"class":47},"Colospan Ltd.","INDUSTRY",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100502783","safety-and-effectiveness-evaluation-of-the-colo-bt-as-an-alternative-treatment-to-the-ileostomy-100502783","NCT05826743","Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy","Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy","COLO-BT","Inclusion Criteria:\n\nThe patient must meet all study Inclusion Criteria as outlined below:\n\n* Adult males or females, 19-80 years of age, with signed informed consent\n\n  * Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm \\\u003C inclusion target ≤ 15cm from the anus).\n\n    ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage\\[6,7,8\\] is true, the patient will be considered a high-risk subject:\n\n    \\- Male\n\n    \\- Those with a body mass index of 30 or higher\n\n    \\- Current smoker\n\n    \\- Those who are on medication for diabetes\n\n    \\- Those with clinical stage III or higher malignant tumors\n\n    \\- Those who received chemo\u002Fradiation therapy before surgery\n\n    ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations\n\n    ⑤ Those who have willingness to undertake blood transfusion if required.\n\nExclusion Criteria:\n\nPatients meeting any of the following Exclusion Criteria will not be eligible to participate in the study:\n\n1. Women who are pregnant or breastfeeding\n2. Those who receive emergency surgery\n3. A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:\n\n   * Patients with abnormal bone marrow function (those with hemoglobin less than 7g\u002Fdl, leukocyte count less than 4000\u002Fmm3, or platelet count less than 100,000\u002Fmm3 even after preoperative corrections)\n   * Patients with severe liver damage or cirrhosis (those whose AST\u002FALT levels are more than three times the normal range or those diagnosed with cirrhosis)\n   * Those with abnormal renal function (those who are on hemodialysis or who have a blood creatinine level of 2.0mg\u002Fdl or more before the surgery)\n   * Those who have undergone cardiac or cerebrovascular stent procedure within the last 6 months\n   * Those who have been diagnosed with pulmonary tuberculosis within the last 6 months or are undergoing drug treatment for pulmonary tuberculosis\n   * Those who continuously administer steroids of 20mg\u002Fday or more within 30 days before the surgery\n   * Patients with ASA (American Society of Anesthesiologists) score of 3 are evaluated by the investigator who determines whether or not patients with ASA score of 3 should be enrolled from the patient safety standpoint. Patients with ASA score higher than 3 are excluded from this study.\n   * Patients who are required to undergo re-intervention to treat the anastomosis following intraoperative positive air leak test (However, patients who underwent complete reconstruction of the anastomosis in the presence of a positive air test, which therefore has made their risk of leak similar to those patients with a negative air leak test.)\n   * Patients who are immune suppressed\n   * Patients with severe diverticulosis\n   * Patients with other colonic wall abnormalities in the likely area of the Outer Balloon and BT BAND application who may be at increased risk for device perforation or migration.\n4. A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric\u002Fneurologic disorder falling under one or more of the following:\n\n   * Those diagnosed with dementia or Alzheimer's disease.\n   * Those who have been diagnosed with schizophrenia or depression or are taking drugs due to this.\n   * A person who has been diagnosed with disability due to intellectual disability.\n5. Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.\n6. Those who have a history of undergoing major surgeries (major bowel resection\u002Fmajor gastrectomy, major hepatectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery.\n7. A patient who underwent a preoperative chemotherapy, but the anastomosis is expected to be located very close to the anus or in the anal canal, thus with a very high risk for complications of the anastomosis, or a patient whom the bowel function is expected to decrease significantly in the future.\n8. Patients who had pre-operative radiotherapy should be excluded.\n9. Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease.\n10. Those who do not consent in writing to the study.\n11. Experienced blood loss (\\>750 cc) within 6 weeks before randomization.\n12. Transfusion during surgery.\n13. Any new sign of ischemia within 6 weeks before randomization.\n14. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization.\n15. Known hypersensitivity or allergy to any of the components required for the procedure.\n16. Exclusion criteria not specified above, but the patient is determined to be unsuitable for participation in this clinical study at the judgment of the researcher.",true,"19 Years","80 Years",{"count":61,"type":21},256,[24],"The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)",[65,66,29,67,68],"Colorectal Surgery","Colorectal Cancer","Ileostomy - Stoma","Anastomotic Leakage",[65,66,70,34,71],"Stoma","Anastomotic leakage","2025-06-12",{"date":74,"type":40},"2025-06-13",{"date":76,"type":40},"2023-12-04",{"date":78,"type":21},"2027-03-15",{"name":80,"class":47},"JSR Medical Co., Ltd.",3]