CraniotomyNCT07758790
A Registry Study to Assess SYNTHECELTM Dura Repair
An observational study of Craniotomy, run by DePuy Synthes Products, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2026to 31 Mar 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.
Who may be able to join
- 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
Who cannot join
- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SYNTHECELTM Dura Repair Registry
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.
- Conditions
- Craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SYNTHECEL Dura Repair | Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics Characteristic Of Participants: Age
Participant's age at time of surgery will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Sex
Participant's sex will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Race
Participant's race will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Ethnicity
Participant's ethnicity will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Height
Participant's height will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Weight
Participant's weight will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Body Mass Index (BMI)
Participant's BMI will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Targeted Medical And Surgical History
Participant's targeted medical and surgical history will be reported.
Measured: At baseline
Demographics Characteristic Of Participants: Diagnosis/Indication
Participants primary diagnosis/indication for surgery will be reported.
Measured: 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.
Measured: At baseline
Baseline imaging assessment
Participant's imaging assessment (MRI or CT scan) will be reported.
Measured: At baseline
Date of Procedure
Date of procedure will be reported.
Measured: Intraoperative
Size of Dura Defect
Size of dura defect will be reported.
Measured: Intraoperative
Surgical Approach
Surgical approach used will be reported.
Measured: Intraoperative
Procedure Time
Procedure time is defined as first incision to final closure.
Measured: Intraoperative
Amount of Blood Loss
Amount of blood loss during craniotomy or craniectomy procedure will be reported.
Measured: Intraoperative
Device Details
Device information will be reported.
Measured: Intraoperative
Device Location
Device location will be reported.
Measured: Intraoperative
Cerebrospinal Fluid (CSF),Drainage Device Use
Use of CSF drainage device will be reported.
Measured: Intraoperative
Dural Adhesive or Dural Sealant Use
Use of dural adhesive or dural sealant will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At discharge (within 1 to 14 days following the index procedure)
Number of Days Since Craniectomy
Number of Days since craniectomy will be reported.
Measured: At discharge (within 1 to 14 days following the index procedure)
Cranioplasty Operative Time
Cranioplasty operative time will be reported.
Measured: At discharge (within 1 to 14 days following the index procedure)
Length of Hospital Stay
Length of hospital stay will be reported.
Measured: 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.
Measured: Intraoperative
Adhesion Formation
Adhesion formation at dura repair site will be reported.
Measured: Intraoperative
Membrane formation
Membrane formation at dura repair site will be reported.
Measured: Intraoperative
Abnormal Thickening
Abnormal thickening at the SYNTHECEL implant site will be reported.
Measured: Intraoperative
Brain Edema
Brain edema adjacent to SYNTHECEL site will be reported.
Measured: Intraoperative
CSF Leakage
CSF leakage at dura repair site will be reported.
Measured: Intraoperative
Pseudomeningocele
Pseudomeningocele at dura repair site will be reported.
Measured: Intraoperative
Discontinuation Status
Participant's discontinuation status will be reported.
Measured: Up to 24 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DePuy Synthes Product, Inc. Clinical Trial, Study director, DePuy Synthes Product, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758790
- Sponsor's protocol ID
- DST202503
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNTHECELTM Dura Repair Registry
- ClinicalTrials.gov ID
- NCT07758790
- Acronym / sponsor ID
- DST202503
- Conditions
- Craniotomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYNTHECEL Dura Repair | – | –Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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
Related trials for Craniotomy
Recruiting
rTMS for Postoperative Brain Tumor Patients
Brain Tumors, Transcranial Magnetic Stimulation
Not yet recruiting
Sphenopalatine Ganglion Block Combined With Either Scalp Nerve Block or Local Wound Infiltration for Postoperative Analgesia in Adult Patients Undergoing Craniotomy: A Randomized Controlled Trial
Craniotomy Surgery
Active, not recruitingObservational study
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures
Recruiting
Perioperative Multimodal Analgesia for Supratentorial Craniotomy
Postoperative Pain, Analgesia
Recruiting
A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Brain Tumor, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DePuy Synthes Product, Inc. Clinical Trial study director
DePuy Synthes Product, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniotomy, run by DePuy Synthes Products, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Farhat (484-356-9705, RA-DST202503@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics Characteristic Of Participants: Age (time frame: At baseline). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.