An observational study in Craniotomy, sponsored by DePuy Synthes Products, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by DePuy Synthes Products, Inc. (part of Johnson & Johnson) · Observational
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.
DePuy Synthes Products, Inc. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Participant with documented or known or allergic reaction to cellulose or related materials
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair.
Demographics Characteristic Of Participants: Age
Participant's age at time of surgery will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Sex
Participant's sex will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Race
Participant's race will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Ethnicity
Participant's ethnicity will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Height
Participant's height will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Weight
Participant's weight will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Body Mass Index (BMI)
Participant's BMI will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Targeted Medical And Surgical History
Participant's targeted medical and surgical history will be reported.
Time frame: At baseline
Demographics Characteristic Of Participants: Diagnosis/Indication
Participants primary diagnosis/indication for surgery will be reported.
Time frame: At baseline
Baseline Neurological Assessment
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.
Time frame: At baseline
Baseline imaging assessment
Participant's imaging assessment (MRI or CT scan) will be reported.
Time frame: At baseline
Date of Procedure
Date of procedure will be reported.
Time frame: Intraoperative
Size of Dura Defect
Size of dura defect will be reported.
Time frame: Intraoperative
Surgical Approach
Surgical approach used will be reported.
Time frame: Intraoperative
Procedure Time
Procedure time is defined as first incision to final closure.
Time frame: Intraoperative
Amount of Blood Loss
Amount of blood loss during craniotomy or craniectomy procedure will be reported.
Time frame: Intraoperative
Device Details
Device information will be reported.
Time frame: Intraoperative
Device Location
Device location will be reported.
Time frame: Intraoperative
Cerebrospinal Fluid (CSF),Drainage Device Use
Use of CSF drainage device will be reported.
Time frame: Intraoperative
Dural Adhesive or Dural Sealant Use
Use of dural adhesive or dural sealant will be reported.
Time frame: Intraoperative
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to 3 years and 3 months
Neurological Status at Discharge
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.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Imaging Assessment at Discharge
Imaging assessment (MRI or CT scan) will be reported at the time of discharge.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Overall Length of Hospital Stay
Participant's overall length of hospital stay will be reported.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Number of Days Since Craniectomy
Number of Days since craniectomy will be reported.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Cranioplasty Operative Time
Cranioplasty operative time will be reported.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Length of Hospital Stay
Length of hospital stay will be reported.
Time frame: At discharge (within 1 to 14 days following the index procedure)
Type of Cranioplasty Implant
Type of cranioplasty implant used in surgery will be reported.
Time frame: Intraoperative
Adhesion Formation
Adhesion formation at dura repair site will be reported.
Time frame: Intraoperative
Membrane formation
Membrane formation at dura repair site will be reported.
Time frame: Intraoperative
Abnormal Thickening
Abnormal thickening at the SYNTHECEL implant site will be reported.
Time frame: Intraoperative
Brain Edema
Brain edema adjacent to SYNTHECEL site will be reported.
Time frame: Intraoperative
CSF Leakage
CSF leakage at dura repair site will be reported.
Time frame: Intraoperative
Pseudomeningocele
Pseudomeningocele at dura repair site will be reported.
Time frame: Intraoperative
Discontinuation Status
Participant's discontinuation status will be reported.
Time frame: Up to 24 months post-index procedure
No study locations are listed for this record.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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