NCT07765862尚未招募不适用
A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 228
- 主要终点
- The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
研究概览
简要总结
The purpose of the NEOFIX study is to evaluate the safety and efficacy of ArtiFix® dural sealant graft in comparison to usual treatment for Dural repair (membrane that covers the brain and spinal cord) following cranial and spine surgeries. The investigated device will be implanted during the neurosurgical procedure and participants will be evaluated at 16, 36 and 120 days after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-operative inclusion criteria:
- •Male or female aged ≥18 and <80 years.
- •Subject is scheduled for an elective cranial or spine surgery with a potential[EG4.1] dural defect that can be repaired by ArtiFix® graft or Control. The maximal estimated dural defect is 25cm2 with an intact dural margins of at least 5 mm surrounding the defect.
- •Subject has undergone MRI or CT that includes the planned implantation area in the past 6 months before screening.
- •Surgical wound is expected to be Class I/clean.
- •Subject understands the study requirements and procedures and provides written Informed Consent before any study-specific tests or procedures. Subject is able and willing to adhere to the follow-up visits and tests.
- •Intra-operative Inclusion criteria:
- •CSF leakage is observed from the dural defect, either spontaneously or during a Valsalva maneuver.
- •The ArtiFix® or control can cover a maximum dural defect size of 25 cm². The dural defect must be suitable for coverage with at least 5 mm of intact dural surface surrounding the defect.
排除标准
- •Pre-operative exclusion criteria:
- •Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
- •Subject is unable to undergo MRI after the surgery (only closed bore MRI is allowed; open bore is not allowed).
- •Subject is an acute cranial or spine traumatic surgical case or diagnosed as nontraumatic hemorrhagic CVA that requires urgent craniectomy.
- •Subject is operated to repair Chiari malformation, or with a transsphenoidal approach, or that their surgery involves penetration of air cells, of any kind.
- •Subject had a previous surgery in the same anatomical site.
- •Subject has known hydrocephalus or other CSF obstruction disorder or has been treated for hydrocephalus with shunt insertion in the past 10 years.
- •Subject is currently or was diagnosed in the past 5 years with malignancy, excluding basal cell carcinoma or low-grade tumors (i.e., meningioma, ependymoma, schwannoma, hemangioblastoma and other tumors defined as low grade, are eligible to participate).
- •Intra-operative Valsalva maneuver poses a risk to the subject, as determined by the surgeon or the anesthesiologist.
- •Subject has a local or systemic infection (e.g. urinary tract infection, active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, or positive blood culture.
- •Subject has a compromised immune system or an active autoimmune disease, or is on immunosuppressant agents, long term anti-inflammatory biological agents or is on chronic systemic steroid treatment (excluding peri-operative steroid treatment).
- •Subjected is diagnosed with sepsis, or systemic collagen disease.
- •Subject at high risk of delayed or failed wound healing due to past treatments or conditions.
- •Subject has been diagnosed with kidney failure regardless of grade, as evident by serum creatinine levels >1.3 mg/dL.
- •Subject was diagnosed with liver disease evident by any of the following test results: ALT > 55 U/L, AST > 48 U/L, ALP > 129 U/L, GGT > 61 U/L, Total bilirubin > 1.3 mg/dL, Albumin < 3.5 g/Dl, INR > 1.2, or PT > 15 sec.
- •Subject has been diagnosed with an uncontrolled diabetes mellitus, as evident by HbA1c > 7%, or suffered recurrent episodes of hypoglycemia in the past 2 months.
- •Subject had chemotherapy and/or radiotherapy in the past 8 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 8 weeks after surgery.
- •Subject requires an external ventricular or lumbar CSF drain that must be left in place after surgery.
- •Subject has congenital or acquired coagulopathy.
- •The subject was classified as exhibiting drug abuse.
- •Subject has any condition that, in the Principal Investigator's judgment, may compromise the subject's safety or preclude compliance with the study investigation plan and/or device instructions.
- •Subject is participating in another clinical trial that tests any other drug or device.
- •Subject is pregnant or breast-feeding at screening or intends to become pregnant during the study period.
- •Subject has known history of sensitivity or allergy to any component of the ArtiFix®.
- •Intra-operative Exclusion criteria:
- •Dural gap is ≤ 2 mm in cranial procedures. In spine procedures the minimal dural gap is not limited.
研究组 & 干预措施
ArtiFix the investigational device
Experimental
干预措施: ArtiFix® is a surgical dural sealant graft intended to close dural defects following cranial and spine surgeries. (Device)
Standard of care treatment
Active Comparator
干预措施: Standard of Care (Investigator Choice) (Device)
结局指标
主要结局
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
时间窗: at 120 days after ArtiFix® or control implantation
The absence of device-related CSF leakage or re-operation of the implantation site within 120 days after implantation.
时间窗: at 120 days after ArtiFix® implantation.
次要结局
未报告次要终点
研究者
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