[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colo-rectal-anastomosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colo-rectal-anastomosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4},"100658723","megagon-magnet-anastomosis-plus-otoloc-for-creating-colo-colonic-and-colorectal-anastomoses-100658723",false,"NCT07856342","Megagon Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses","GI Windows Megagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures","FOCUS II","Inclusion Criteria:\n\n1. Aged 22 years or older at screening\n2. Candidate for surgery requiring Colo-colonic or colo-rectal (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 ≥ 1 month 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 for magnet passage\n7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon\n8. Coagulation deficiency not normalized by medical treatment or platelet count \\\u003C50,000\u002FµL\n9. Known moderate to severe renal disease (eGFR \\\u003C 44 milliliters per minute per 1.73m2) or ongoing dialysis\n10. Hyperkalemia \u002F hypercoagulability or prior Venous Thromboembolism \u002F Pulmonary Embolism\n11. 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.\n\n    * A minimum cessation window of four (4) weeks prior to surgery for all biologic agents\n    * Restarted no earlier than four (4) weeks postoperatively\n12. 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)\n13. Decompensated chronic obstructive lung disease\n14. Active or suspected infection at the surgical site or a CDC Class 3\u002Fcontaminated or Class 4\u002Fdirty-infected surgical wound.\n15. Contraindication to general anesthesia\n16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period\n17. Currently participating or has participated in another clinical trial within the past 30 days and \u002F or is receiving\u002Fhas received an investigational drug, device, or biologic agent within past 4 weeks\n18. 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},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of this trial is to investigate the safety and effectiveness of the Megagon 28.5mm SFM system plus OTOLoc when used to create a colo-colonic and colorectal anastomosis in participants undergoing colon surgery. This will be evaluated via a composite safety\u002Feffectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.",[27],"Colo-rectal Anastomosis","NOT_YET_RECRUITING","2026-09-28",{"date":31,"type":32},"2026-10-02","ACTUAL",{"date":34,"type":21},"2026-11-16",{"date":36,"type":21},"2027-03-30",{"name":38,"class":39},"GI Windows, Inc.","INDUSTRY"]