[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-anastomosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-anastomosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100586472","flexagon-plus-otoloc-colon-anastomosis-in-patients-undergoing-surgery-100586472",false,"NCT06915818","Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery","GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures","FOCUS","Inclusion Criteria:\n\n1. Aged 22 years or older at screening\n2. Candidate for surgery requiring Right Hemicolectomy or Sigmoid \u002F Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac\u002Fmedical clearance for surgery\n3. Able to understand and sign informed consent document\n4. American Society of Anesthesiologists (ASA) score \\\u003C IV at time of procedure\n5. All cancer patients must have completed chemotherapy ≥2 months prior to procedure\n6. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study\n7. Able to refrain from smoking during study follow-up period\n\nExclusion Criteria:\n\n1. Known or suspected allergy to silicone, nickel, titanium or Nitinol\n2. BMI \\> 55 kg\u002Fm2\n3. Uncontrolled diabetes (defined as HbA1c \\>10%)\n4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet\n5. Diagnosed with obstructed or perforated colon cancer\n6. Any documented conditions for which endoscopy and\u002For laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets\n7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon\n8. History of recurrent small bowel obstructions.\n9. Coagulation deficiency not normalized by medical treatment or platelet count \\\u003C50,000\u002FµL\n10. Known moderate to severe renal disease (eGFR \\\u003C 44 milliliters per minute per 1.73m2) or ongoing dialysis\n11. Hyperkalemia \u002F hypercoagulability or prior Venus Thromboembolism \u002F Pulmonary Embolism\n12. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents\n13. Congestive heart failure with ejection fraction \\\u003C35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)\n14. Decompensated chronic obstructive lung disease\n15. Active or suspected infection at the surgical site or a CDC Class 3\u002Fcontaminated or Class 4\u002Fdirty-infected surgical wound.\n16. Contraindication to general anesthesia\n17. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period\n18. Currently participating or has participated in another clinical trial within the past 30 days and is receiving\u002Fhas received an investigational drug, device, or biologic agent\n19. Contraindication to general anesthesia\n20. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator","ALL","22 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.",[27],"Colon Anastomosis","RECRUITING","2026-02-12",{"date":31,"type":32},"2026-02-13","ACTUAL",{"date":34,"type":32},"2025-03-29",{"date":36,"type":21},"2026-07",{"name":38,"class":39},"GI Windows, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100600699","seal-g-seal-g-mist-long-term-follow-up-pmcf-continue-study-100600699","NCT07100886","Seal-G\u002F Seal-G MIST Long-Term Follow-up PMCF (Continue) Study","Long-Term Safety and Efficacy Evaluation of Seal-G and Seal-G MIST Surgical Sealants for Anastomosis Protection in Colon Surgery [PMCF Study Continuation]","Inclusion Criteria:\n\n* Treatment Group: Patients participated and completed all visits in the previous PMCF study (treatment group; #DLG-072-06)\n* Control Group: comparable retrospective subjects that meet the same inclusion criteria specified in #DLG-072-06.\n* Both Treatment \\& Control group:\n\nWilling to comply with long-term follow-up assessment (including oral consent).\n\nExclusion Criteria:\n\n* Both Treatment \\& Control group:\n\nPatients who are unable or unwilling to complete the phone questionnaire.\n\n\\- Control group: Subjects that would have been excluded according to the previous PMCF study #DLG-072-06 exclusion criteria.\n\n* Patients with missing or incomplete medical records that prevent retrospective comparison.\n* Patients that during the original surgery received any treatment on the anastomosis (sealant\u002Fglue) except for the anastomosis closure technique (sutures\u002Fstaple).\n* Original surgery included stoma creation.","18 Years","85 Years",{"count":50,"type":21},208,"OBSERVATIONAL","Postoperative complications following colon anastomosis surgery, such as adhesions, stenosis, stricture and obstruction, can significantly impact patient outcomes. The use of surgical sealants has been proposed as a means to mitigate anastomotic complications by providing a protective barrier over the anastomosis site, reducing the risk or the severity of anastomotic leak. The previous post-market clinical follow-up (PMCF) study assessed the short-term safety and performance of SEAL-G surgical sealants in preventing anastomotic leaks and early post-operative complications. However, long-term data are needed to establish its sustained safety and effectiveness.\n\nThis continuation study aims to evaluate the long-term impact of the SEAL-G\u002FMIST surgical sealant on post-operative complications over 12+ months after surgery. The study will compare complication rates in patients treated with the surgical sealant to a retrospective comparable control group who underwent similar procedures without the sealant.",[27],"NOT_YET_RECRUITING","2025-07-28",{"date":57,"type":32},"2025-08-03",{"date":59,"type":21},"2025-08-04",{"date":61,"type":21},"2026-01-30",{"name":63,"class":39},"Advanced Medical Solutions Ltd."]