A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes- NEOART Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 18
- 主要终点
- Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.
研究概览
简要总结
The objective of this study was to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in subjects requiring Dural repair following neurosurgery.
Subjects with planned cranial neurosurgery participated in this study. During the surgery the dura is likely to be cut and damaged. A damaged dura can cause a leakage of brain fluids (cerebrospinal fluid [CSF] leakage) and increase the risk of infections. The damaged dura can be fixed with dural patch like ArtiFascia®. ArtiFascia® is a bioabsorbable medical synthetic dural replacement that aids in the regeneration of a new dura. Furthermore, it incorporates a sealing layer capable of minimizing CSF leakage and infection.
详细描述
A Prospective, randomized, controlled multi-center study of ArtiFascia® Dural repair patch compared with commercially available dural substitutes- NEOART Study.
The dura mater is a fibrous connective tissue that surrounds the nervous system (brain and spinal cord) and provides a mechanical barrier that contains the cerebrospinal fluid (CSF). The dura mater may be damaged as a result of trauma or planned surgery. When dural defects cannot be repaired by primary closure, a dural substitute must be utilized in order to reduce CSF leakage.
There are devices that have been used as dural substitutes. Among the devices that are based on natural raw materials, collagen-based matrices are widely used. Although collagen was proven to be biocompatible, using collagen-based materials still possess several limitations such as CSF leaks. Synthetic dural substitutes are also used to repair dura mater. The most widely used raw-material for these synthetic products are polyesters - resorbable and biocompatible polymers. There are several dural substitutes based on synthetic polyesters that were successfully tested pre-clinically as well as in human studies.
Sponsor of this study has developed the ArtiFascia®. ArtiFascia® is a polymeric synthetic dural substitute that is absorbed by the body.
Before the study, all subjects underwent neurological assessment. Only subjects that were found to be suitable to participate in the study, and agree to participate, were randomly allocated into one of the following groups:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject between the ages of 18-75
- •Subject is scheduled for an elective cranial surgery with a dural damage that can be completely repaired/closed by a suture-able dural substitute (ArtiFascia device or other commercially available dural substitutes)
- •Subject has undergone radiographic imaging (such as, MRI) in the past 6 months before enrolment
- •Surgical wound is expected to be Class I/clean
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- •Subject is able and willing to adhere to the required follow-up visits and testing
排除标准
- •Pregnant women or interest in becoming pregnant during the duration of the study
- •Subject has known hydrocephalus
- •Subject is unable to undergo MRI after the surgery
- •Subject's life expectancy is less than 12 months
- •Subject has a local or systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 38.3℃, positive blood culture and/or a positive chest x-ray for acute infectious process
- •Subject will require use of dural adhesive or sealant
- •Subject is intended to undergo craniectomy wherein bone flap will not be returned
- •Subject with suspected low success in wound healing due to past treatments (e.g. chemotherapy, radiation therapy, severe diabetes etc.) or other conditions (e.g. severe peripheral vascular disease, long standing steroids treatment)
- •Subject has been clinically diagnosed with malignancy (other than basal cell carcinoma or low-grade glioma), uncontrolled diabetes (A1C>6.5%), sepsis, systemic collagen disease.
- •Subject had chemotherapy and/or radiotherapy in the past 12 weeks before surgery or is planned to have chemotherapy or radiotherapy less than 12 weeks after surgery.
- •Subject is an acute cranial trauma surgical case
- •Subjects with a concurrent disease that would place the patient in excessive risk to the planned surgery
- •Subject had a previous neurosurgery in the same anatomical site
- •Subject with other undesirable symptoms defined by the principal investigator
- •Patient has clinically significant coagulopathy as determined by the surgeon
- •Subject is participating in another clinical trial using similar investigational devices/drugs
结局指标
主要结局
Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging.
时间窗: 6 month.
The primary end point will be assessed by evaluating the absence of cerebrospinal fluid fistula (drainage from wound or sinus) and pseudo-meningocele post-operative as evaluated by MRI imaging and physical examination of the surgical site.
次要结局
- Wound Healing Assessment(6 month follow-up)
- Device Handling Characteristics as Reported by a User Experience Questionnaire(On the day of the surgical procedure)
- Radiological Imaging at 6 Months for Additional Findings at Implant Site(6 month follow-up)