[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600699":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":32,"slug":10,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":10,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":10,"studyType":44,"phases":10,"briefSummary":45,"conditions":46,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"Advanced Medical Solutions Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retrospective Treatment Group",null,"Patients who underwent colectomy and anastomosis coverage with Seal-G \u002F Seal-G MIST as part of the previous PCMF study protocol (#DLG-072-06)",[13],"Other: long-term follow up visit",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective Control Group","Patients who underwent colon resection with primary anastomosis (SOC) (comparable population)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"OTHER","long-term follow up visit","Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Naama Giwnewer, Clinical Manager","CONTACT","+972506979691","naamag@admedsol.co.il",{"type":31,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100600699",false,"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.","ALL","18 Years","85 Years",{"count":42,"type":43},208,"ESTIMATED","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.",[47],"Colon Anastomosis","NOT_YET_RECRUITING","2025-07-28",{"date":51,"type":52},"2025-08-03","ACTUAL",{"date":54,"type":43},"2025-08-04",{"date":56,"type":43},"2026-01-30",{"name":5,"class":6}]