[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644098":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":50,"responsibleParty":86,"collaborators":90,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"National Defense Medical Center, Taiwan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CMT Vessel-X ® Bone Filling Container System","EXPERIMENTAL","Subjects undergo percutaneous vertebral augmentation using the CMT Vessel-X® Bone Filling Container System (Model: BVFT-UP01-D20). Under fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body. The microporous PET Vessel-X® Bone Filling Container is deployed within the vertebral body and subsequently filled with TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) to stabilize the vertebral compression fracture.",[13],"Device: CMT Vessel-X® Bone Filling Container System",{"label":15,"type":16,"description":17,"interventionNames":18},"CMT Conventional Vertebroplasty","ACTIVE_COMPARATOR","Subjects undergo percutaneous vertebroplasty using the CMT Manual Orthopedic Surgical Instruments (Model: T-C308). Under real-time fluoroscopic guidance, a unilateral transpedicular approach is used to access the fractured vertebral body, and TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z) is directly injected into the vertebral body to stabilize the vertebral compression fracture.",[19],"Device: CMT Manual Orthopedic Surgical Instruments",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CMT Vessel-X® Bone Filling Container System","Model: BVFT-UP01-D20 (TFDA No. 005889, GMP0106), manufactured by Central Medical Technologies Inc. (marketed since Aug 2017). An EO-sterilized, single-use, implantable kit for percutaneous vertebral augmentation (store \\\u003C= 25°C, shelf-life: 5 years). The kit includes:\n\n1. Vessel-X® Bone Filling Container (Model: BVFX-D20): An implantable, microporous PET container to enclose cement and minimize leakage.\n2. Front-Opening Cement Injection Device with Extension Tube (Model: T-C308, max 20 ml): For controlled hydraulic delivery.\n3. Percutaneous Access Tools: Includes 1pc Bone Access Needle (T-N201T), 1pc Guide Pin (T-P602), and 1pc Precision Drill (T-D401).\n\n   * Intervention Cement: TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888), used during vertebral augmentation procedures for injection into the affected vertebra to stabilize vertebral compression fractures.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"CMT Manual Orthopedic Surgical Instruments","The CMT Manual Orthopedic Surgical Instruments (Model: T-C308; TFDA License No. 005698) are nonimplantable manual surgical instruments intended for conventional vertebroplasty procedures. The device functions as a manual cement delivery system for the injection of TEKNIMED OPACITY+ Radiopaque Bone Cement (Model: T040320Z; TFDA License No. 026888) into the vertebral body to stabilize vertebral compression fractures.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Dr. Chih-Chien Wang, Ph.D.","Trial-Service General Hospital, National Defense Medical University","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Yu-Hsu Chen, Ph.D.","Taoyuan General Hospital, Ministry of Health and Welfare",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Juin-Hong Cherng, Ph.D.","CONTACT","886-2-87923100","18681, 18699","i72bbb@gmail.com",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Gang-Yi Fan, Ph.D.","18699","u9310318@gmail.com",[51,68],{"facility":52,"status":53,"city":54,"state":26,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Tri-Service General Hospital, National Defense Medical Univesity","RECRUITING","Taipei","114202","Taiwan","TW",{"type":59,"coordinates":60},"Point",[61,62],121.52639,25.05306,{"lat":62,"lon":61},[65,67],{"name":41,"role":42,"phone":43,"phoneExt":66,"email":45},"18698, 18699",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},{"facility":69,"status":53,"city":54,"state":26,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"National Defense Medical University, Taiwan","11490",{"type":59,"coordinates":72},[61,62],{"lat":62,"lon":61},[75,77,78,80,81,84],{"name":41,"role":42,"phone":76,"phoneExt":66,"email":45},"886-2-8792-3100",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},{"name":79,"role":35,"phone":26,"phoneExt":26,"email":26},"Chih-Chern Wang, Ph.D.",{"name":37,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":82,"role":83,"phone":26,"phoneExt":26,"email":26},"Yi-Chou Chen, Ｍ.D.","SUB_INVESTIGATOR",{"name":85,"role":83,"phone":26,"phoneExt":26,"email":26},"Chien-Ning Hsu, Ｍ.D.",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Juin-Hong Cherng","Associate Professor",[91,93],{"name":92,"class":6},"Tri-Service General Hospital",{"name":94,"class":95},"Taoyuan General Hospital","OTHER_GOV","100644098","safety-and-efficacy-clinical-trial-of-the-vessel-x-bone-filling-container-system-100644098",false,"NCT07665424","Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System","The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System","CMT-VX","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Male or female subjects aged ≥40 and ≤95 years.\n2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.\n3. Surgical site within the range of T6 to L5.\n4. Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation.\n5. Subjects willing to comply with the study schedule and all required assessment procedures.\n6. Subjects who are conscious, cognitively intact, and able to provide written informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.\n2. Active or severe systemic infections.\n3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.\n4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.\n5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.\n6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.\n7. Active infection at or adjacent to the surgical site.\n8. Acute spinal instability.\n9. Unwillingness or inability to restrict physical activity or comply with medical instructions.\n10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.","ALL","40 Years","95 Years",{"count":108,"type":109},146,"ESTIMATED","INTERVENTIONAL",[112],"NA","Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.\n\nThe Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.\n\nThis post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:\n\nTri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nTaoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nThe primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.",[115,116],"Osteoporosis","Osteoporotic Vertebral Compression Fractures",[118,119,120,121,23,122,123,124,125],"Oswestry Disability Index","Visual Analogue Scale","Serious Adverse Device Effect","Last Observation Carry Forward","Vesselplasty","Kyphoplasty","Vertebroplasty","Osteoporotic vertebral compression fractures (OVCFs)","2026-06-22",{"date":128,"type":129},"2026-06-24","ACTUAL",{"date":131,"type":129},"2021-04-20",{"date":133,"type":109},"2026-12-31",{"name":88,"class":6},2]