SYNTHECELTM Dura Repair Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Demographics Characteristic Of Participants: Age
研究概览
简要总结
The purpose of this study is to assess how safe synthecel dura repair is and how well it performs in participants undergoing cranial surgery requiring dura repair (a procedure to close and protect the outer covering of the brain) in a regular, everyday healthcare environment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant or legally authorized representative who is willing to participate in the registry and provide written informed consent
- •Participant undergoing SYNTHECEL implantation for cranial dura repair on or after the start date of the registry study
排除标准
- •- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials
研究组 & 干预措施
SYNTHECEL Dura Repair
Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair.
结局指标
主要结局
Demographics Characteristic Of Participants: Age
时间窗: At baseline
Participant's age at time of surgery will be reported.
Demographics Characteristic Of Participants: Sex
时间窗: At baseline
Participant's sex will be reported.
Demographics Characteristic Of Participants: Race
时间窗: At baseline
Participant's race will be reported.
Demographics Characteristic Of Participants: Ethnicity
时间窗: At baseline
Participant's ethnicity will be reported.
Demographics Characteristic Of Participants: Height
时间窗: At baseline
Participant's height will be reported.
Demographics Characteristic Of Participants: Weight
时间窗: At baseline
Participant's weight will be reported.
Demographics Characteristic Of Participants: Body Mass Index (BMI)
时间窗: At baseline
Participant's BMI will be reported.
Demographics Characteristic Of Participants: Targeted Medical And Surgical History
时间窗: At baseline
Participant's targeted medical and surgical history will be reported.
Demographics Characteristic Of Participants: Diagnosis/Indication
时间窗: At baseline
Participants primary diagnosis/indication for surgery will be reported.
Baseline Neurological Assessment
时间窗: At baseline
Participant's neurological assessment (function) will be reported. Neurological assessment will be reported in a qualitative manner and all assessments will be collected and reported by the hospital site based on the standard clinical practice for the respective institution. Presence of abnormal neurological findings (Yes/No) as determined by neurological assessment will be recorded.
Baseline imaging assessment
时间窗: At baseline
Participant's imaging assessment (MRI or CT scan) will be reported.
Date of Procedure
时间窗: Intraoperative
Date of procedure will be reported.
Size of Dura Defect
时间窗: Intraoperative
Size of dura defect will be reported.
Surgical Approach
时间窗: Intraoperative
Surgical approach used will be reported.
Procedure Time
时间窗: Intraoperative
Procedure time is defined as first incision to final closure.
Amount of Blood Loss
时间窗: Intraoperative
Amount of blood loss during craniotomy or craniectomy procedure will be reported.
Device Details
时间窗: Intraoperative
Device information will be reported.
Device Location
时间窗: Intraoperative
Device location will be reported.
Cerebrospinal Fluid (CSF),Drainage Device Use
时间窗: Intraoperative
Use of CSF drainage device will be reported.
Dural Adhesive or Dural Sealant Use
时间窗: Intraoperative
Use of dural adhesive or dural sealant will be reported.
Number of Participants with Adverse Events (AEs)
时间窗: Up to 3 years and 3 months
Adverse event is any untoward medical occurrence (sign, symptom, or disease) in a subject that is deemed at least possibly related to use of SYNTHECEL, and or the procedure.
Neurological Status at Discharge
时间窗: At discharge (within 1 to 14 days following the index procedure)
Neurological status at the time of discharge will be reported. Neurological assessment will be reported in a qualitative manner and all assessments will be collected and reported by the hospital site based on the standard clinical practice for the respective institution. Presence of abnormal neurological findings (Yes/No) as determined by neurological assessment will be recorded.
Imaging Assessment at Discharge
时间窗: At discharge (within 1 to 14 days following the index procedure)
Imaging assessment (MRI or CT scan) will be reported at the time of discharge.
Overall Length of Hospital Stay
时间窗: At discharge (within 1 to 14 days following the index procedure)
Participant's overall length of hospital stay will be reported.
Number of Days Since Craniectomy
时间窗: At discharge (within 1 to 14 days following the index procedure)
Number of Days since craniectomy will be reported.
Cranioplasty Operative Time
时间窗: At discharge (within 1 to 14 days following the index procedure)
Cranioplasty operative time will be reported.
Length of Hospital Stay
时间窗: At discharge (within 1 to 14 days following the index procedure)
Length of hospital stay will be reported.
Type of Cranioplasty Implant
时间窗: Intraoperative
Type of cranioplasty implant used in surgery will be reported.
Adhesion Formation
时间窗: Intraoperative
Adhesion formation at dura repair site will be reported.
Membrane formation
时间窗: Intraoperative
Membrane formation at dura repair site will be reported.
Abnormal Thickening
时间窗: Intraoperative
Abnormal thickening at the SYNTHECEL implant site will be reported.
Brain Edema
时间窗: Intraoperative
Brain edema adjacent to SYNTHECEL site will be reported.
CSF Leakage
时间窗: Intraoperative
CSF leakage at dura repair site will be reported.
Pseudomeningocele
时间窗: Intraoperative
Pseudomeningocele at dura repair site will be reported.
Discontinuation Status
时间窗: Up to 24 months post-index procedure
Participant's discontinuation status will be reported.
次要结局
未报告次要终点