[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586435":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":29,"locations":35,"responsibleParty":75,"collaborators":20,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":20,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"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 gastric-jejunal anastomosis using the Flexagon SFM Device with OTOLoc.",[13],"Device: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc","This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and\u002For endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. 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],{"name":23,"affiliation":24,"role":25},"Mohit Bhandari, MD","Bhandari Hospital & Research Centre","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Pablo Marin, MD","Clinica Colonial Hospital",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Peter Lukin","CONTACT","+1 7814717901","peter.lukin@giwindows.com",[36,57],{"facility":28,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"NOT_YET_RECRUITING","Santiago","Huechuraba, Región Metropolitana","8580000","Chile","CL",{"type":44,"coordinates":45},"Point",[46,47],-70.64827,-33.45694,{"lat":47,"lon":46},[50,53],{"name":27,"role":32,"phone":51,"phoneExt":20,"email":52},"+56982947291","doctorpablomarin@gmail.com",{"name":54,"role":32,"phone":55,"phoneExt":20,"email":56},"Francesca Gorziglia, MD","+56985007583","francesca.gorziglia@gmail.com",{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Mohak Hitech Specialty Hospital","RECRUITING","Indore","Madhya Pradesh","454555","India","IN",{"type":44,"coordinates":66},[67,68],75.8333,22.71792,{"lat":68,"lon":67},[71,74],{"name":72,"role":32,"phone":73,"phoneExt":20,"email":20},"Mohit Bhandari","(+91) 7314231753",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":76,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100586435","magnet-anastomosis-in-patients-undergoing-gastric-surgery-100586435",false,"NCT06915337","Magnet Anastomosis in Patients Undergoing Gastric Surgery","GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures","MAPS","Inclusion Criteria:\n\n1. Aged 22 years or older at screening\n2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis 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. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study\n6. 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\n7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas 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 Venus 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\n12. Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication\n13. Active or suspected infection at the surgical site or a CDC Class 3\u002Fcontaminated or Class 4\u002Fdirty-infected surgical wound.\n14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician\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 is receiving\u002Fhas received an investigational drug, device, or biologic agent\n18. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator","ALL","22 Years",{"count":88,"type":89},75,"ESTIMATED","INTERVENTIONAL",[92],"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 gastro-jejunal anastomosis in participants undergoing gastric surgery.",[95],"Gastric Anastomosis (Site)","2026-02-12",{"date":98,"type":99},"2026-02-13","ACTUAL",{"date":101,"type":99},"2025-03-29",{"date":103,"type":89},"2026-06",{"name":5,"class":6},2]