[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658723":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":33,"centralContacts":38,"locations":13,"responsibleParty":44,"collaborators":13,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":13,"enrollmentInfo":56,"targetDuration":13,"studyType":59,"phases":60,"briefSummary":61,"conditions":62,"keywords":13,"overallStatus":64,"whyStopped":13,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":13},{"fullName":5,"class":6},"GI Windows, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Endpoint","The study's primary endpoint (patient success) is defined as successful anastomosis created with the Megagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.","30 Days",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","This is a prospective, single-center, single-arm clinical study.\n\nPatients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be evaluated for participation in the study.\n\nUp to 30 participants undergoing colo-colonic and colorectal anastomoses with the Megagon 28.5mm SFM system plus OTOLoc.\n\nPatients providing informed consent and meeting all eligibility criteria will be scheduled for surgery. All operations will be conducted by experienced general surgeons and gastroenterologists trained in the use of the Megagon SFM System plus OTOLoc, and procedures will be performed under general anesthesia. The anastomosis formation is achieved by creation of a colotomy in the (colon) utilizing a standard electrosurgical hook or equivalent, delivery of the OTOLoc into the colotomy, followed by delivery of the Megagon SFM through the OTOLoc into the colon with the FlexFire Universal 2, FlexFire delivery tools and the transrectal Nexus delivery system. Upon deployment, the SFM assembly self-forms into its closed octagonal shape and is ready for coupling with the second SFM. The same process is used for the second location in the rectum or colon. When the two SFMs are positioned to be in close proximity, coupling occurs, clamping the targeted intestinal tissue together, thereby starting the formation of a compression anastomosis.\n\nAfter surgery, participants will be started on clear liquids and ambulation on the day of the procedure through postoperative Day 2. On postoperative Day 3, the diet will be advanced to full liquids excluding dairy products. On postoperative Day 5, participants may progress to a regular diet excluding all high-fiber foods (specifically vegetables, fruits, oatmeal, legumes, and other high-residue foods). Unrestricted regular diet will be permitted after postoperative Day 10. All dietary progression is subject to individual participant tolerance and investigator judgment. All participants will be required to stay in the hospital a minimum of one night per standard of care (SOC).\n\nClinical follow-up for all participants will occur at Discharge, Day 7, 30, and 60.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Patients who are scheduled for laparoscopic or hybrid colon surgery requiring an anastomosis will be","EXPERIMENTAL","Anastomosis",[27],"Device: Megagon Self-Forming Magnet",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32,"otherNames":13},"DEVICE","Megagon Self-Forming Magnet",[23],[34],{"name":35,"affiliation":36,"role":37},"Mohit Bhandari, MD","Mohak Hitech Specialty Hospital","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Peter Lukin COO","CONTACT","9787610183","peter.lukin@giwindows.com",{"type":45,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","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":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[15],"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.",[63],"Colo-rectal Anastomosis","NOT_YET_RECRUITING","2026-09-28",{"date":67,"type":68},"2026-10-02","ACTUAL",{"date":70,"type":58},"2026-11-16",{"date":72,"type":58},"2027-03-30",{"name":5,"class":6}]