[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tissium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651039","secure-post-market-study-100651039",false,"NCT07756489","SECURE Post-Market Study","SECURE Post-Market Study (PMS): Atraumatic Sutureless Nerve Repair - Evaluation of COAPTIUM CONNECT in a REal-World Clinical Setting","SECURE PMS","Inclusion Criteria:\n\n1. Subjects aged 18 years or older at the time of signing the informed consent form.\n2. Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:\n\n   1. Digital sensory nerve with associated tendon injury, OR\n   2. Digital sensory nerve without tendon injury.\n3. Nerve must be completely transected and appropriate for primary repair.\n4. Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.\n5. Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.\n6. Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.\n7. Subject is willing and able to provide written informed consent prior to any study specific procedures.\n8. Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to any constituents of the product, including the polymer (Aminated polyglycerol sebacate acrylate) or the additive FD\\&C Blue No. 1 Dye (brilliant blue FCF);\n2. Known diagnosis of peripheral neuropathy;\n3. Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;\n4. Subject's traumatic lesion is older than 14 days at the time of surgery;\n5. Use of photosensitizing medications at the time of informed consent.\n6. Concomitant neuromodulator medication;\n7. Life expectancy less than 1 year;\n8. History of neuropathic pain in the affected extremity;\n9. History of injury to the nerve being studied;\n10. Missing contralateral digit or history of injury to the contralateral digit (comparison\u002Fcontrol area);\n11. Unwillingness\u002Finability to follow postoperative instructions\u002Ffollow-up visits;\n12. Concomitant intake of systemic immunosuppressive medications, steroids (\\>20mg of prednisone \u002Fday or equivalent) and chemotherapy;\n13. Prior radiation therapy to the surgical site;\n14. Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;\n15. History of chronic ischemic disease involving the affected limb;\n16. Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);\n17. Subject is currently participating in a study involving an investigational device\u002Fdrug that has not reached its primary endpoints or would interfere with the study endpoints.\n\n    Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;\n18. Previous injury, surgery, pathology involving the same nerve or extremity;\n19. Active infection at the surgical site;\n20. In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.","ALL","18 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this post-market study is to generate post-market, real- world evidence on the safety and performance of COAPTIUM® CONNECT with TISSIUM® LIGHT for the atraumatic sutureless repair of acute digital (sensory) injuries of the hand in adults through prospective data collection, to confirm safety and performance of the device.",[27,28],"Acute Peripheral Nerve Injuries","Digital Nerve Injury","NOT_YET_RECRUITING","2026-08-04",{"date":32,"type":33},"2026-08-10","ACTUAL",{"date":35,"type":21},"2026-10",{"date":37,"type":21},"2028-10",{"name":39,"class":40},"Tissium","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100614311","atraumatic-laparoscopic-hernia-repair-clinical-investigation-to-evaluate-the-safety-and-performance-of-the-eclipsium-system-for-mesh-fixation-ide-100614311","NCT07277946","AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE","UNITE","Inclusion Criteria:\n\n1. Patient is 22 years old or older.\n2. Patient is willing and able to provide a signed Patient Informed Consent Form.\n3. Patient has a single midline primary ventral, umbilical, or incisional hernia;\n\n   a.Hernia Size is 1 -5 cm in diameter (to be confirmed intraoperatively).\n4. Patient is scheduled for a laparoscopic IPOM hernia repair.\n5. Hernia can be successfully repaired with a single polyester or polypropylene composite mesh with biodegradable coating with at least a 5 cm overlap of the mesh on all sides of the defect (to be confirmed intraoperatively).\n6. Female patients must:\n\n   1. Have a negative urine pregnancy test within 3 days before surgery and agree to consistently use an effective method of contraception through completion of study participation.\n\n      OR\n   2. Have reached menopause (no menses for 1 year). OR\n   3. Have undergone hysterectomy, bilateral oophorectomy, or tubal ligation.\n7. Patient is willing and able to follow the study instructions including completion of study procedures, assessments, and visits.\n\nExclusion Criteria:\n\n1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, comparator device, mesh, or other surgical products (e.g., sutures).\n2. Patient is taking systemic photosensitivity pharmaceutical products at time of informed consent.\n3. Patient has a BMI \\> 40.\n4. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day.\n5. Patient's hernia is recurrent and\u002For the patient has a previous midline primary ventral, umbilical, or incisional hernia repair with mesh implantation.\n6. Patient has a life expectancy less than 1 year, in the opinion of the Investigator.\n7. Patient is unwilling or unable to follow postoperative instructions.\n8. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent.\n9. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding.\n10. Patient has a diagnosis of Type 1 Diabetes Mellitus.\n11. Patient has uncontrolled Type 2 Diabetes Mellitus (HbA1C ≥ 7.0 within 3 months preceding study enrolment).\n12. Patient is currently participating in an investigational drug or device study that has not completed the primary outcome or that clinically interferes with this clinical study's outcome (Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies).\n13. Patient has more than one hernia defect (single hernia defect between 1-5 cm in diameter from outer edged to outer edge to be confirmed intraoperatively).\n14. Patient has areas of weakness, independent from the hernia to be treated, in the area covered by mesh or mesh-adjacent tissues (to be confirmed intraoperatively).\n15. Patient with a complex hernia, likely not eligible for laparoscopic repair, as determined by the Investigator (ex. small bowel resection; to be confirmed intraoperatively).\n16. Patient is scheduled for an additional surgery within 6 weeks after the index-procedure or has undergone surgery within 90 days before the index-procedure.\n17. Patient has severe chronic obstructive pulmonary disease.\n18. Patient has an ongoing infection (e.g. elevated temperature, elevated white blood count).\n19. In the opinion of the Investigator, the patient is not a suitable candidate for the clinical investigation.","22 Years",{"count":50,"type":21},240,[24],"The primary purpose of this clinical trial is to assess the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. The study will evaluate whether ECLIPSIUM, a bioresorbable polymer-based fixation device, is effective in reducing the risk of hernia recurrence when compared with bioresorbable tacks. This information will support understanding of ECLIPSIUM's potential clinical benefits in ventral hernia repair.",[54],"Hernia",[56,54,57],"Ventral Hernia Repair","Hernia Repair","RECRUITING","2026-06-08",{"date":61,"type":33},"2026-06-09",{"date":63,"type":33},"2026-05-14",{"date":65,"type":21},"2026-12",{"name":39,"class":40},12,""]