[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Averto Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100546993","coloseal-icd-system-safety-and-feasibility-study-100546993",false,"NCT06402188","ColoSeal™ ICD System Safety and Feasibility Study","European ColoSeal™ ICD System Safety and Feasibility Study","Inclusion Criteria:\n\n* Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.\n* Subject is diagnosed with rectosigmoid or rectal cancer\n* Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).\n* The subject 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* Subject must be willing and able to comply with study follow-up requirements.\n\nExclusion Criteria:\n\n* Subject with a life expectancy \\\u003C 1 year\n* Subjects with ASA classification \\> 3\n* Albumin \\\u003C 30 g\u002Fliter\n* Subject has local or systemic infection at the time of intervention.\n* Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study\n* Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure\n* Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease\n* Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function\n* Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression\n* BMI ≥ 40\n* Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)\n* Subject has been taking regular systemic\u002F steroid medication in the last 3 months\n* Subjects is taking antimetabolites or antiplatelet agents (with the exception of aspirin)\n* Subject has undergone a prior pelvic anastomosis\n* Subject requires an end-to-end anastomosis smaller than 31 mm in diameter\n* Inadequate bowel preparation prior to the procedure\n* Anastomotic leak detected during intraoperative leak testing\n* Known allergy to any component of the device\n* Known allergy to iodine or iodine-based contrast unless subject can be adequately premedicated prior to leak test\n* Subject has unresolved alcohol abuse or illegal drug use\n* Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data\n* Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure\n* Subject is unable or unwilling to provide informed consent\n* Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints","ALL","18 Years","70 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.",[27],"Colorectal Cancer",[29,30,31,32],"Colon anastomosis","Rectosigmoid cancer resection","Ostomy","Colon diversion","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2023-06-05",{"date":41,"type":21},"2026-12-31",{"name":43,"class":44},"Averto Medical, Inc.","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100625936","coloseal-icd-system-anastomotic-protection-pivotal-study-100625936","NCT07429110","ColoSeal™ ICD System Anastomotic Protection Pivotal Study","Inclusion Criteria:\n\n1. Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.\n2. Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score \\\u003C12 seconds). This inclusion applies to subjects aged 71-75 only.\n3. Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).\n4. Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.\n5. Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).\n6. Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.\n7. Subject should live within ≤ 75 miles (120 km) of their study investigator's facility. If outside of this range, subjects must be willing to stay in accommodations ≤ 75 miles (120 km) of the investigator's facility for 1-day post-study device removal.\n8. Subject must be willing and able to comply with protocol requirements, including study follow-up visits.\n\nExclusion Criteria:\n\nPreoperative:\n\n1. Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.\n2. Subject with a life expectancy \\\u003C 1 year due to condition other than rectal cancer.\n3. Subject with American Society of Anesthesiologists (ASA) classification \\> 3.\n4. Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.\n5. Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.\n6. Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.\n7. Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.\n8. Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function.\n9. Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count \\\u003C150,000\u002FμL), or immune suppression (CD4+ T-cell count \\\u003C500 cells\u002Fmm³).\n10. Subject has a condition resulting in significant cognitive impairment and\u002For functional decline, such as dementia or advanced Parkinsons disease.\n11. Subject has a BMI ≥ 40.\n12. Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).\n13. Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.\n14. Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.\n15. Subject has undergone a prior pelvic anastomosis.\n16. Subject has fecal incontinence, involvement of the sphincter by neoplastic disease, or evidence of extensive local disease in the pelvis seen on pre-operative imaging.\n17. Subject is diabetic with hemoglobin A1c \\> 8.0% (64 mmol\u002Fmol).\n18. Serum albumin of \\\u003C 3.0 g\u002FdL.\n19. Serum prealbumin of \\\u003C15mg\u002FdL.\n20. Subject has a known allergy to any component of the device.\n21. Subject has a known allergy to iodine or iodine-based contrast unless the subject can be adequately premedicated before the leak test.\n22. Subject has unresolved alcohol or drug abuse, in the investigator's opinion.\n23. Subject is pregnant or planning to become pregnant (female subjects of childbearing potential must have a negative urinary pregnancy test ≤ 7 days before the surgical procedure).\n24. Subject is unable or unwilling to provide informed consent.\n25. Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.\n\n    Intraoperative:\n26. Subject is not planned to receive an ostomy placement at the time of the index procedure.\n27. Subject's left colon (bowel) preparation on the day of surgery is deemed inadequate for ICD Device placement, as determined by the investigator.\n28. Subject requires an end-to-end or side-to-end anastomosis smaller than 31 mm in diameter or greater than 10cm from the anal verge.\n29. Subject failed intraoperative leak test.\n30. Subject has any condition or abnormality which, in the opinion of the investigator, may jeopardize subject safety or the quality of the study data.","22 Years","75 Years",{"count":55,"type":21},250,[24],"The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.",[59],"Rectal Cancer Surgery",[61,62,63,64],"Rectal Cancer","Diverting Ostomy","Stoma","Anastomosis","NOT_YET_RECRUITING","2026-02-18",{"date":68,"type":37},"2026-02-24",{"date":70,"type":21},"2026-04",{"date":72,"type":21},"2028-02",{"name":43,"class":44},""]