[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586472":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":31,"locations":37,"responsibleParty":76,"collaborators":20,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":20,"enrollmentInfo":88,"targetDuration":20,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":20,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"GI Windows, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Group: Prospective Evaluation of Flexagon SFM Device with OTOLoc","EXPERIMENTAL","This is a multicenter, single-arm study in which clinical outcomes are prospectively evaluated for subjects undergoing ileo-colic and colo-colonic anastomosis using the Flexagon SFM Device with OTOLoc.",[13],"Device: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc","This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and\u002For endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum\u002Fcolon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.",[9],null,[22,26,28],{"name":23,"affiliation":24,"role":25},"Mohit Bhandari, MD","Mohak Hitech Specialty Hospital","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":24,"role":25},"Vinod Dhakkad, MD",{"name":29,"affiliation":30,"role":25},"Pablo Marin, MD","Clinica Colonial Hospital",[32],{"name":33,"role":34,"phone":35,"phoneExt":20,"email":36},"Peter Lukin","CONTACT","+1 7814717901","peter.lukin@giwindows.com",[38,59],{"facility":30,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"NOT_YET_RECRUITING","Santiago","Huechuraba, Región Metropolitana","8580000","Chile","CL",{"type":46,"coordinates":47},"Point",[48,49],-70.64827,-33.45694,{"lat":49,"lon":48},[52,55],{"name":29,"role":34,"phone":53,"phoneExt":20,"email":54},"+56982947291","doctorpablomarin@gmail.com",{"name":56,"role":34,"phone":57,"phoneExt":20,"email":58},"Francesca Gorziglia, MD","+56985007583","francesca.gorziglia@gmail.com",{"facility":24,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"RECRUITING","Indore","Madhya Pradesh","454555","India","IN",{"type":46,"coordinates":67},[68,69],75.8333,22.71792,{"lat":69,"lon":68},[72,74,75],{"name":23,"role":34,"phone":73,"phoneExt":20,"email":20},"(+91) 7314231753",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":27,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":77,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":89,"type":90},65,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96],"Colon Anastomosis","2026-02-12",{"date":99,"type":100},"2026-02-13","ACTUAL",{"date":102,"type":100},"2025-03-29",{"date":104,"type":90},"2026-07",{"name":5,"class":6},2]