[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Quanta Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100474659","first-in-human-study-of-mattisse-tissue-engineering-chamber-in-adult-female-patients-undergoing-breast-reconstruction-after-mastectomy-for-cancer-100474659",false,"NCT05460780","First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer","First-in-human Study of MATTISSE® Tissue Engineering Chamber in Adult Female After Total Mastectomy for Breast Cancer in Immediate or Delayed 2-stage Tissue Expander Reconstruction or Conversion From Implant-based to Autologous Reconstruction","TIDE","Inclusion Criteria:\n\nCriteria related to pathology:\n\n* Female patient over 18 Years old\n* Patient who required autologous breast reconstruction:\n\n  * Immediate unilateral reconstruction after total mastectomy for early-stage breast cancer\n  * Breast reconstruction after unilateral preventive total mastectomy\n  * or delayed unilateral reconstruction after total mastectomy for early-stage breast cancer with a tissue expander implantation\n  * or conversion from implant-based to autologous reconstruction: Patient who had a breast implant during a previous reconstruction after total mastectomy for cancer, and who needs to change it.\n* For patient with active cancer: Patient with early-stage cancer (stage 0, I or II, with tumor size \\\u003C 50mm, without lymph-node involvement) needing oncological management that does not required radiotherapy after surgery on the breast area or on the flap donor site\n* Patient who required Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion; or implant removal for patient undergoing autologous conversion, or expender removal for patient undergoing differed reconstruction.\n* Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.\n* Patient medically fit for surgery without significant comorbidities\n* Breast cup-size less than D\n* Body mass index \\>20 kg\u002Fm2 or patient for whom sufficient flap volume is expected according to surgeon's assessment\n* Adequate hematopoietic functions\n\nCriteria related to population:\n\n* Subjects who have given free, informed and written consent to participate in the study;\n* Patient able to answer questionnaires, able to communicate in the language of the study country;\n* Subjects affiliated to a social security schema or entitled to a social security scheme.\n\nNon-inclusion Criteria:\n\nPathology related criteria:\n\n* Patient undergoing bilateral reconstruction\n* Patient undergoing bilateral preventive mastectomy\n* Patient undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation\n* Previous history of radiotherapy on the breast area or on the flap donor site\n* Previous history of breast or axillary surgery that does not allow fat flap dissection\n* Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI\n* Body mass index \\>30 kg\u002Fm2\n* Taking medication for weight loss at the time of inclusion visit\n* Presence of major medical conditions that may compromise patient's health and healing\n* Diabetes and a history of gestational diabetes\n* Active smoking\n* Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)\n* Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination\n* Allergy to anesthetics or contrast media\n* Immunocompromised patient (HIV) or patient used immunosuppressants\n\nPopulation related criteria\n\n* Pregnant patient\n* or breastfeeding patient or woman who has nursed a child three months within inclusion\n* Participation in a clinical trial in the 3 months prior to the initial visit\n* Predicted unavailability during study.\n* Patient deprived of liberty or under guardianship.\n* Patient unable to give consent\n\nMedical device related criteria\n\n* Allergy to any of the components of the medical device.\n\nEXCLUSION CRITERIA\n\n* Positive or suspicious extemporaneous sentinel node biopsy\n* Non integrity of LICAP and LTAP vessels, showed by the pre-operative doppler\n* Patient not yet implanted with MATTISSE®, whose cancer stage will finally require radiotherapy treatment","FEMALE","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a first in human, two-stage single arm non-comparative study of safety and performance.\n\nThe aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.",[27,28,29],"Breast Cancer Female","Breast Cancer Prevent","Breast Reconstruction","RECRUITING","2025-03-18",{"date":33,"type":34},"2025-03-20","ACTUAL",{"date":36,"type":34},"2022-07-01",{"date":38,"type":21},"2028-12-31",{"name":40,"class":41},"Quanta Medical","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100445994","study-of-the-effectiveness-of-a-polymer-cerclage-system-compared-to-cerclages-used-in-standard-care-cercpmcf--100445994","NCT05087667","Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )","Outcomes of Adjuvant \"Polymer Cerclage System \"OrthoLoop\" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.","SERRE","Inclusion Criteria:\n\n* patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below:\n* Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s)\n* Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s)\n* Peri-prosthetic fracture of the femur or humerus\n* Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages\n* who underwent fixation with cerclage wiring (Sterile Self Locking Polymer Cerclage System or other cerclage systems used in standard care)\n* age ≥18 years\n* Who have given free, informed and written consent to participate in the study\n* Patient able to communicate in French\n* Patient affiliated to a social security system or entitled to a social security system\n\nExclusion Criteria:\n\n* high-energy injury,\n* associated damage to other long bones,\n* fracture extension to the articular surface with displacement\n* Severe disease that could interfere with the study results or be life threatening\n* Patients with an infection\n* Allergy to any component of the medical products\n* Pregnant or breastfeeding women\n* Anticipated unavailability during the study\n* Participation in a clinical trial within 3 months prior to the inclusion visit.\n* Patient with linguistic or psychological incapacity to understand and sign the informed consent.\n* Patient deprived of liberty by administrative or judicial decision, or being under guardianship.","ALL",{"count":52,"type":21},202,[24],"The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population.\n\nWhether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip\u002Fshoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.\n\nThe \"Sterile Self Locking Polymer Cerclage System\" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications.\n\nThus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care.\n\nSERRE is a 36 months follow up study in two arms :\n\n* Experimental group: \"OrthoLoop cercalge\"\n* Control group: \"cerclages used in standard care\" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.\n\nThe main objective of this study is to assess the role of \"OrthoLoop cerclage\" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.",[56],"Femoral Fracture",{"date":33,"type":34},{"date":59,"type":34},"2022-03-08",{"date":61,"type":21},"2028-12",{"name":40,"class":41},15,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":50,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100393768","efficacy-and-tolerance-study-of-b-dyn-versus-conventional-fusion-in-the-treatment-of-lumbar-stenosis-on-the-degree-of-post-operative-functional-incapacity-bdynclin-100393768","NCT04407338","Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)","Study of the Efficacy and Tolerance of the B-Dyn Medical Device Compared to a Conventional Bolted Fusion With or Without Cage in the Treatment of Degenerative Lumbar Stenosis, With or Without Grade I Spondylolisthesis on the Degree of Postoperative Functional Disability, Preservation of Mobility and Prevention of the Adjacent Syndrome\". Interventional, Prospective, Comparative, Randomized, Non-inferiority, Single Blind, International, Multicenter Clinical Study","BDYNCLIN","Inclusion Criteria:\n\nDisease related criteria:\n\n1. Stenosis on 1, 2 or 3 disc levels (grade B or C or D according to Schizas classification or central stenosis of grade A according to Schizas classification with a lateral stenosis (postero-lateral overhang or disc protrusion)) on MRI (lumbar spine MRI )\n2. Spondylolisthesis grade 1 or no the upper surgical (treated) level\n3. Neurological impairment or neurogenic claudication on one or both legs (VAS score \\> 30)\n4. Subjects who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms \\> 3 months);\n5. Subjects with no contraindication to fusion or the application of B-Dyn®.\n\nPopulation-related criteria\n\n1. Subjects of both sexes, 40 years of age and older\n2. Subjects who have given free, informed and written consent to participate in the study;\n3. Subjects who are able to respond to questionnaires and who can communicate in the language of the study country ;\n4. Subjects affiliated to a social security scheme or entitled to a social security scheme.\n\nExclusion Criteria:\n\nDisease related criteria:\n\n1. Spondylolisthesis of grade \\> 1 on the upper surgical (treated) level\n2. Intervention required on more than 3 disc levels\n3. Degenerative Scoliosis (Cobb angle \\> 20°);\n4. Stenosis located only on the L5-S1 level\n5. History of instrumented lumbar surgery (cage, rod, etc.) on the upper or lower level, except in the case of instrumentation of the lower level with an intra-spinous device.\n6. Stenosis not caused by from degenerative changes.\n7. Isolated disc herniation\n8. Other specific vertebral damage (for example: ankylosing spondylitis, cancer or neurological disorders)\n9. History of vertebral compression fractures at the instrumented level\n10. History of osteoporotic fractures\n11. Psychological disorders (e.g. dementia ….etc) or drug addiction that lead to an inability to participate in the study\n12. Chronic infection\n\nPopulation related criteria:\n\n1. Withdrawal of consent;\n2. Pregnant or Breastfeeding woman\n3. Participation in a clinical trial in the 3 months prior to the initial visit;\n4. Predicted unavailability during study. Patient deprived of liberty or under guardianship.\n\nMedical Device related criteria:\n\n1\\. Allergy to any of the components of the medical device.","40 Years",{"count":74,"type":21},216,[24],"Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back. It causes pain and even disorders of the lower limbs. When the symptoms get worse and the individual feels functional discomfort despite medical treatment, surgical intervention is recommended. Two surgical options are available: Rigid Stabilization Devices as conventional fusion with or without cage, or dynamic stabilization system as B-DYN device, this system is called \"dynamic\" because it allows the stabilization of the operated part while preserving a certain mobility.\n\nThe main objective of this study is to evaluate the efficacy and tolerance of B-Dyn versus conventional bolted fusion (with or without cage) in the treatment of degenerative lumbar stenosis (DLS) on the degree of postoperative functional incapacity. So the investigator's hypothesis is that the use of the B-DYN device in the treatment of DLS could lead to the maintenance of functional disability related to low back pain (maintenance of walking and mobility).\n\nAnother important point to be demonstrated in this study is the preservation of the mobility of the stage overlying the assembly performed by B-Dyn. Indeed, the continued degeneration of segments adjacent to lumbar vertebral fusions is a concern for surgeons For B-Dyn, which is a dynamic stabilization, the combination of rigid and flexible parts allows the mobility of the overlying stage to be preserved and could also lead to a decrease in adjacent syndrome in the long-term compared to the use of conventional fusion.\n\nThe duration of patient follow-up is 60 months. The inclusion period is 56 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).",[78],"Degenerative Lumbar Spinal Stenosis",[80,81,82,83],"Spine","Arthrodesis","Dynamic stabilisation","BDYN",{"date":85,"type":34},"2025-03-19",{"date":87,"type":34},"2020-06-01",{"date":89,"type":21},"2029-11-01",{"name":40,"class":41},2,""]