A Registry Study to Assess SYNTHECELTM Dura Repair

Primary outcomes

1. Demographics Characteristic Of Participants: Age

   Time frame: At baseline

   Participant's age at time of surgery will be reported.

2. Demographics Characteristic Of Participants: Sex

   Time frame: At baseline

   Participant's sex will be reported.

3. Demographics Characteristic Of Participants: Race

   Time frame: At baseline

   Participant's race will be reported.

4. Demographics Characteristic Of Participants: Ethnicity

   Time frame: At baseline

   Participant's ethnicity will be reported.

5. Demographics Characteristic Of Participants: Height

   Time frame: At baseline

   Participant's height will be reported.

6. Demographics Characteristic Of Participants: Weight

   Time frame: At baseline

   Participant's weight will be reported.

7. Demographics Characteristic Of Participants: Body Mass Index (BMI)

   Time frame: At baseline

   Participant's BMI will be reported.

8. Demographics Characteristic Of Participants: Targeted Medical And Surgical History

   Time frame: At baseline

   Participant's targeted medical and surgical history will be reported.

9. Demographics Characteristic Of Participants: Diagnosis/Indication

   Time frame: At baseline

   Participants primary diagnosis/indication for surgery will be reported.

10. 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.

11. Baseline imaging assessment

    Time frame: At baseline

    Participant's imaging assessment (MRI or CT scan) will be reported.

12. Date of Procedure

    Time frame: Intraoperative

    Date of procedure will be reported.

13. Size of Dura Defect

    Time frame: Intraoperative

    Size of dura defect will be reported.

14. Surgical Approach

    Time frame: Intraoperative

    Surgical approach used will be reported.

15. Procedure Time

    Time frame: Intraoperative

    Procedure time is defined as first incision to final closure.

16. Amount of Blood Loss

    Time frame: Intraoperative

    Amount of blood loss during craniotomy or craniectomy procedure will be reported.

17. Device Details

    Time frame: Intraoperative

    Device information will be reported.

18. Device Location

    Time frame: Intraoperative

    Device location will be reported.

19. Cerebrospinal Fluid (CSF),Drainage Device Use

    Time frame: Intraoperative

    Use of CSF drainage device will be reported.

20. Dural Adhesive or Dural Sealant Use

    Time frame: Intraoperative

    Use of dural adhesive or dural sealant will be reported.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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.

26. Cranioplasty Operative Time

    Time frame: At discharge (within 1 to 14 days following the index procedure)

    Cranioplasty operative time will be reported.

27. Length of Hospital Stay

    Time frame: At discharge (within 1 to 14 days following the index procedure)

    Length of hospital stay will be reported.

28. Type of Cranioplasty Implant

    Time frame: Intraoperative

    Type of cranioplasty implant used in surgery will be reported.

29. Adhesion Formation

    Time frame: Intraoperative

    Adhesion formation at dura repair site will be reported.

30. Membrane formation

    Time frame: Intraoperative

    Membrane formation at dura repair site will be reported.

31. Abnormal Thickening

    Time frame: Intraoperative

    Abnormal thickening at the SYNTHECEL implant site will be reported.

32. Brain Edema

    Time frame: Intraoperative

    Brain edema adjacent to SYNTHECEL site will be reported.

33. CSF Leakage

    Time frame: Intraoperative

    CSF leakage at dura repair site will be reported.

34. Pseudomeningocele

    Time frame: Intraoperative

    Pseudomeningocele at dura repair site will be reported.

35. Discontinuation Status

    Time frame: Up to 24 months post-index procedure

    Participant's discontinuation status will be reported.