Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
99
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Barrow Neurosurgical Institute
Scottsdale, Arizona, United States
Stanford Medical Center
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
Oregon Health Sciences University
Portland, Oregon, United States
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Time frame: 6 months
Modified Rankin Scale (Patient Function Assessment)
Time frame: up to 6 months
Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Time frame: up to 6 months
Wound Healing Assessment
Time frame: up to 6 months
Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Time frame: up to 6 months
Radiographic Evaluation
Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit) * Adhesion formation * Membrane formation * Abnormal thickening along graft (device implant) site * Brain edema adjacent to graft (device implant) site
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Texas
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
West Virginia University School of Medicine
Morgantown, West Virginia, United States