At a glance
ClinicalIndex Comparison RecordN/ACompleted· 98 enrolled
Drug / intervention
Spinal Sealant +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 and Standard of Care for Cerebrospinal Fluid Leakage, Subdural. Completed, enrolled 98 participants across 1 site.
Detailed Summary
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrospinal Fluid Leakage, Subdural
CountriesUnited States
CollaboratorsMedtronic - MITG
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartMay 2007
Primary CompletionAug 2009
TodayJul 2026
First PostedMar 7, 2007
Enrollment StartMay 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.3 years ago
Interventions
Spinal Sealantdevice
Spinal Sealant System
Standard of Careother
Standard of Care