CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
SyntheCel +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00859508
NCT00859508N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery

Synthes USA HQ, Inc.·interventional·Posted Mar 11, 2009·Updated Mar 8, 2012

In Brief

A clinical study evaluating SyntheCel and Other FDA cleared dura replacements for Cranial Dura Repair. Completed, enrolled 99 participants across 8 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCranial Dura Repair
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 11, 2009
Enrollment StartFeb 1, 2006
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.3 years ago

Interventions

SyntheCeldevice

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.

Other FDA cleared dura replacementsdevice

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.