[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Advanced Medical Solutions Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"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":20,"type":21},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.",[25],"Colon Anastomosis","NOT_YET_RECRUITING","2025-07-28",{"date":29,"type":30},"2025-08-03","ACTUAL",{"date":32,"type":21},"2025-08-04",{"date":34,"type":21},"2026-01-30",{"name":36,"class":37},"Advanced Medical Solutions Ltd.","INDUSTRY",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":45,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":47,"conditions":48,"keywords":52,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100541205","inoss-mbcp-putty-ortho-100541205","NCT06326827","In'Oss™ (MBCP® Putty) Ortho","Study of the Osteoconductive Potential of the Injectable Bone Substitute In'Oss™ (MBCP® Putty) in the Filling of Orthopaedic Bone Defects","Inclusion Criteria:\n\n1. Patient is male or female, 18 - 85 years old;\n2. Patient is willing and able to give written informed consent;\n3. Patient is able to comply with a prior medical examination;\n4. Patient is or has been scheduled for a surgical procedure to correct epiphyso-metaphyseal and\u002For metaphyso-diaphyseal bone defect in one of the following anatomical locations:\n\n   * Proximal humerus ▪ Distal radius\n   * Distal femur ▪ Proximal tibia ▪ Distal tibia\n5. Patient is willing and able to comply with the study procedures during surgery and the post-surgical follow up period, up to 12 months.\n\nExclusion Criteria:\n\n1. Patient has had an infection in the same extremity within last 24 months;\n2. Patient has signs of necrosis at the surgical site;\n3. Patient has cellulitis;\n4. Patient has granuloma or non-curetted cyst;\n5. Patient has an history of uncontrolled diabetes;\n6. Patient is alcoholic and\u002For heavy smoker (\\> 20 cigarettes per day);\n7. Patient has a congenital or acquired immunodeficiency;\n8. Patient has severe bone loss (≥ 40cm3);\n9. Patient is on long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism;\n10. Patient is or has been scheduled for surgery that would involve intra-articular implantation of the study device;\n11. Patient who has or had an uncontained bone defect created as a result of trauma injury or surgically created;\n12. Patient was exposed to any radiation (e.g. X-Rays, handling of radiolabelled materials) other than the normal background radiation within the 12 months before the screening visit;\n13. Patient is pregnant;\n14. Patient who is an employee at the study site;\n15. Patient is known to be non-compliant with medical treatment or follow-up\n16. Patient has any significant or unstable medical\u002Fpsychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study;\n17. Patient is currently enrolled or planning to enrol in another clinical study or treatment with another investigational drug\u002Fdevice that may interfere with the assessments, visits or outcomes of this study.",{"count":46,"type":21},100,"Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery",[49,50,51],"Orthopedic Disorder","Trauma Injury","Extremity Injury",[53,54,55,56,57,58,59,60],"Proximal humerus","Distal radius","Distal femur","Proximal tibia","Distal tibia","Fracture","MBCP Putty","Bone defect reconstruction","2025-02-03",{"date":63,"type":30},"2025-02-05",{"date":65,"type":21},"2025-03",{"date":67,"type":21},"2027-03",{"name":36,"class":37},""]