[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600699":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":43,"overallOfficials":11,"centralContacts":49,"locations":11,"responsibleParty":55,"collaborators":11,"id":57,"slug":11,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":11,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":11},{"fullName":5,"class":6},"Advanced Medical Solutions Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Rate of reoperation due to anastomotic complications",null,"1 year post-surgery",{"measure":14,"description":15,"timeFrame":12},"Assessment of long-term anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)","At least one complication within the 1 year interval",[17,20,22,25],{"measure":18,"description":11,"timeFrame":19},"The incidence of anastomotic complications (i.e. adhesions, stenosis, stricture, and obstruction)","1-4 years post-surgery",{"measure":21,"description":11,"timeFrame":19},"The incidence of hospitalization due to anastomotic complications",{"measure":23,"description":11,"timeFrame":24},"The incidence of reoperation due to anastomotic complications","1-4 years post surgery",{"measure":26,"description":11,"timeFrame":27},"The incidence of anastomotic leaks (Clinical\u002Fsub-clinical)","30 day post surgery",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":29,"timePerspective":30,"maskingInfo":11},"COHORT","RETROSPECTIVE","The study is designed as an observational, retrospective-controlled, long-term follow-up, multi-center post-market clinical follow-up (PMCF) study.\n\nFor the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G \u002F Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures.\n\nFor the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment. Phone Questionnaire: Long-term follow-up visit should be performed via Phone call Questionnaire. Patients will be contacted (including Oral informed consent) to assess long-term outcomes relating to the colon anastomosis surgery they underwent 2-4 years ago.\n\n* Incidence of adhesions, stenosis, and obstruction (reported during the Physician questionnaire and confirmed by medical records review where possible).\n* Need for reoperation due to complications.\n* Use of additional treatments relating to anastomosis complications (e.g., anti-adhesion therapy, bowel obstruction management).","For the Retrospective Treatment Group, 3 out of the 8 sites participated in the previous PMCF study (#DLG-072-06), will be included with a total of 104 patients who received the Seal-G \u002F Seal-G MIST surgical sealant during colon anastomosis surgery 2-4 years ago (during 2021-2023). The following sites were selected due to relatively large number of participants in the previous study and according to their ability to comply with the current study procedures.\n\nFor the Retrospective Control group, screening will be performed at each site, for a matching number of subjects from a comparable population (i.e age; BMI; surgery procedure (2-4 years ago); etc.) that did not receive the sealant treatment.",[34,39],{"label":35,"type":11,"description":36,"interventionNames":37},"Retrospective Treatment Group","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)",[38],"Other: long-term follow up visit",{"label":40,"type":11,"description":41,"interventionNames":42},"Retrospective Control Group","Patients who underwent colon resection with primary anastomosis (SOC) (comparable population)",[38],[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"OTHER","long-term follow up visit","Phone call questionnaire- retrospective treatment arm Phone call questionnaire- retrospective control arm",[40,35],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Naama Giwnewer, Clinical Manager","CONTACT","+972506979691","naamag@admedsol.co.il",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":67,"type":68},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.",[72],"Colon Anastomosis","NOT_YET_RECRUITING","2025-07-28",{"date":76,"type":77},"2025-08-03","ACTUAL",{"date":79,"type":68},"2025-08-04",{"date":81,"type":68},"2026-01-30",{"name":5,"class":6}]