SYNTHECELTM Dura Repair Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 112
- Locations
- 4
- Primary Endpoint
- Demographics Characteristic Of Participants: Age
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials
Arms & Interventions
SYNTHECEL Dura Repair
Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair.
Outcomes
Primary Outcomes
Demographics Characteristic Of Participants: Age
Time Frame: At baseline
Participant's age at time of surgery will be reported.
Demographics Characteristic Of Participants: Sex
Time Frame: At baseline
Participant's sex will be reported.
Demographics Characteristic Of Participants: Race
Time Frame: At baseline
Participant's race will be reported.
Demographics Characteristic Of Participants: Ethnicity
Time Frame: At baseline
Participant's ethnicity will be reported.
Demographics Characteristic Of Participants: Height
Time Frame: At baseline
Participant's height will be reported.
Demographics Characteristic Of Participants: Weight
Time Frame: At baseline
Participant's weight will be reported.
Demographics Characteristic Of Participants: Body Mass Index (BMI)
Time Frame: At baseline
Participant's BMI will be reported.
Demographics Characteristic Of Participants: Targeted Medical And Surgical History
Time Frame: At baseline
Participant's targeted medical and surgical history will be reported.
Demographics Characteristic Of Participants: Diagnosis/Indication
Time Frame: At baseline
Participants primary diagnosis/indication for surgery will be reported.
Baseline Neurological Assessment
Time Frame: 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
Time Frame: At baseline
Participant's imaging assessment (MRI or CT scan) will be reported.
Date of Procedure
Time Frame: Intraoperative
Date of procedure will be reported.
Size of Dura Defect
Time Frame: Intraoperative
Size of dura defect will be reported.
Surgical Approach
Time Frame: Intraoperative
Surgical approach used will be reported.
Procedure Time
Time Frame: Intraoperative
Procedure time is defined as first incision to final closure.
Amount of Blood Loss
Time Frame: Intraoperative
Amount of blood loss during craniotomy or craniectomy procedure will be reported.
Device Details
Time Frame: Intraoperative
Device information will be reported.
Device Location
Time Frame: Intraoperative
Device location will be reported.
Cerebrospinal Fluid (CSF),Drainage Device Use
Time Frame: Intraoperative
Use of CSF drainage device will be reported.
Dural Adhesive or Dural Sealant Use
Time Frame: Intraoperative
Use of dural adhesive or dural sealant will be reported.
Number of Participants with Adverse Events (AEs)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At discharge (within 1 to 14 days following the index procedure)
Number of Days since craniectomy will be reported.
Cranioplasty Operative Time
Time Frame: At discharge (within 1 to 14 days following the index procedure)
Cranioplasty operative time will be reported.
Length of Hospital Stay
Time Frame: At discharge (within 1 to 14 days following the index procedure)
Length of hospital stay will be reported.
Type of Cranioplasty Implant
Time Frame: Intraoperative
Type of cranioplasty implant used in surgery will be reported.
Adhesion Formation
Time Frame: Intraoperative
Adhesion formation at dura repair site will be reported.
Membrane formation
Time Frame: Intraoperative
Membrane formation at dura repair site will be reported.
Abnormal Thickening
Time Frame: Intraoperative
Abnormal thickening at the SYNTHECEL implant site will be reported.
Brain Edema
Time Frame: Intraoperative
Brain edema adjacent to SYNTHECEL site will be reported.
CSF Leakage
Time Frame: Intraoperative
CSF leakage at dura repair site will be reported.
Pseudomeningocele
Time Frame: Intraoperative
Pseudomeningocele at dura repair site will be reported.
Discontinuation Status
Time Frame: Up to 24 months post-index procedure
Participant's discontinuation status will be reported.
Secondary Outcomes
No secondary outcomes reported