[{"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":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":10,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":10,"studyType":45,"phases":10,"briefSummary":46,"conditions":47,"keywords":10,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"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","seal-g-seal-g-mist-long-term-follow-up-pmcf-continue-study-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":43,"type":44},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.",[48],"Colon Anastomosis","NOT_YET_RECRUITING","2025-07-28",{"date":52,"type":53},"2025-08-03","ACTUAL",{"date":55,"type":44},"2025-08-04",{"date":57,"type":44},"2026-01-30",{"name":5,"class":6}]