At a glance
ClinicalIndex Comparison RecordN/ACompleted· 158 enrolled
Drug / intervention
Spinal Sealant System +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.
A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
In Brief
A clinical study evaluating Spinal Sealant System and Standard of care for Spinal Procedure Requiring Dura Incision. Completed, enrolled 158 participants across 1 site.
Detailed Summary
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Procedure Requiring Dura Incision
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2005
First PostedJan 2008
Primary CompletionFeb 2008
Study CompletionApr 2008
TodayJul 2026
First PostedJan 15, 2008
Enrollment StartSep 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.5 years ago
Interventions
Spinal Sealant Systemdevice
Standard of caredevice
Standard of care: devices intended to provide a watertight closure