A Registry Study to Assess SYNTHECELTM Dura Repair

NCT07758790 | Not Yet Recruiting

• 1 other identifier: DST202503
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 4

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.

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (35)

• Demographics Characteristic Of Participants: Age

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

  At baseline

• Demographics Characteristic Of Participants: Sex

  Participant's sex will be reported.

  At baseline

• Demographics Characteristic Of Participants: Race

  Participant's race will be reported.

  At baseline

• Demographics Characteristic Of Participants: Ethnicity

  Participant's ethnicity will be reported.

  At baseline

• Demographics Characteristic Of Participants: Height

  Participant's height will be reported.

  At baseline

• Demographics Characteristic Of Participants: Weight

  Participant's weight will be reported.

  At baseline

• Demographics Characteristic Of Participants: Body Mass Index (BMI)

  Participant's BMI will be reported.

  At baseline

• Demographics Characteristic Of Participants: Targeted Medical And Surgical History

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

  At baseline

• Demographics Characteristic Of Participants: Diagnosis/Indication

  Participants primary diagnosis/indication for surgery will be reported.

  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.

  At baseline

• Baseline imaging assessment

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

  At baseline

• Date of Procedure

  Date of procedure will be reported.

  Intraoperative

• Size of Dura Defect

  Size of dura defect will be reported.

  Intraoperative

• Surgical Approach

  Surgical approach used will be reported.

  Intraoperative

• Procedure Time

  Procedure time is defined as first incision to final closure.

  Intraoperative

• Amount of Blood Loss

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

  Intraoperative

• Device Details

  Device information will be reported.

  Intraoperative

• Device Location

  Device location will be reported.

  Intraoperative

• Cerebrospinal Fluid (CSF),Drainage Device Use

  Use of CSF drainage device will be reported.

  Intraoperative

• Dural Adhesive or Dural Sealant Use

  Use of dural adhesive or dural sealant will be reported.

  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.

  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.

  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.

  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.

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

• Number of Days Since Craniectomy

  Number of Days since craniectomy will be reported.

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

• Cranioplasty Operative Time

  Cranioplasty operative time will be reported.

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

• Length of Hospital Stay

  Length of hospital stay will be reported.

  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.

  Intraoperative

• Adhesion Formation

  Adhesion formation at dura repair site will be reported.

  Intraoperative

• Membrane formation

  Membrane formation at dura repair site will be reported.

  Intraoperative

• Abnormal Thickening

  Abnormal thickening at the SYNTHECEL implant site will be reported.

  Intraoperative

• Brain Edema

  Brain edema adjacent to SYNTHECEL site will be reported.

  Intraoperative

• CSF Leakage

  CSF leakage at dura repair site will be reported.

  Intraoperative

• Pseudomeningocele

  Pseudomeningocele at dura repair site will be reported.

  Intraoperative

• Discontinuation Status

  Participant's discontinuation status will be reported.

  Up to 24 months post-index procedure

Study Arms (1)

SYNTHECEL Dura Repair

Participants undergoing cranial dura repair will be enrolled to monitor the safety and performance of SYNTHECEL dura repair.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes participants undergoing cranial dura repair using SYNTHECEL Dura Repair.

You may qualify if:

• 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

You may not qualify if:

• \- Participant with documented or known hypersensitivity or allergic reaction to cellulose or related materials

Sponsors & Collaborators

• DePuy Synthes Products, Inc.: lead

Study Sites (4)

Cleveland Clinic

Weston, Florida, 33331 3609, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

• DePuy Synthes Product, Inc. Clinical Trial

  DePuy Synthes Product, Inc.

  STUDY DIRECTOR

Central Study Contacts

Maggie Farhat

CONTACT

484-356-9705; RA-DST202503@ITS.JNJ.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 11, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4)