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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Demographics Characteristic Of Participants: Age
Timeframe: At baseline
Demographics Characteristic Of Participants: Sex
Timeframe: At baseline
Demographics Characteristic Of Participants: Race
Timeframe: At baseline
Demographics Characteristic Of Participants: Ethnicity
Timeframe: At baseline
Demographics Characteristic Of Participants: Height
Timeframe: At baseline
Demographics Characteristic Of Participants: Weight
Timeframe: At baseline
Demographics Characteristic Of Participants: Body Mass Index (BMI)
Timeframe: At baseline
Demographics Characteristic Of Participants: Targeted Medical And Surgical History
Timeframe: At baseline
Demographics Characteristic Of Participants: Diagnosis/Indication
Timeframe: At baseline
Baseline Neurological Assessment
Timeframe: At baseline
Baseline imaging assessment
Timeframe: At baseline
Date of Procedure
Timeframe: Intraoperative
Size of Dura Defect
Timeframe: Intraoperative
Surgical Approach
Timeframe: Intraoperative
Procedure Time
Timeframe: Intraoperative
Amount of Blood Loss
Timeframe: Intraoperative
Device Details
Timeframe: Intraoperative
Device Location
Timeframe: Intraoperative
Cerebrospinal Fluid (CSF),Drainage Device Use
Timeframe: Intraoperative
Dural Adhesive or Dural Sealant Use
Timeframe: Intraoperative
Number of Participants with Adverse Events (AEs)
Timeframe: Up to 3 years and 3 months
Neurological Status at Discharge
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Imaging Assessment at Discharge
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Overall Length of Hospital Stay
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Number of Days Since Craniectomy
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Cranioplasty Operative Time
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Length of Hospital Stay
Timeframe: At discharge (within 1 to 14 days following the index procedure)
Type of Cranioplasty Implant
Timeframe: Intraoperative
Adhesion Formation
Timeframe: Intraoperative
Membrane formation
Timeframe: Intraoperative
Abnormal Thickening
Timeframe: Intraoperative
Brain Edema
Timeframe: Intraoperative
CSF Leakage
Timeframe: Intraoperative
Pseudomeningocele
Timeframe: Intraoperative
Discontinuation Status
Timeframe: Up to 24 months post-index procedure