CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
Adherus Dural Sealantdevice
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/NCT01158378
NCT01158378Phase 3Completed
CompareCT.gov

A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

HyperBranch Medical Technology, Inc·interventional·Posted Jul 8, 2010·Updated Apr 8, 2014

In Brief

A Phase 3 clinical trial evaluating Adherus Dural Sealant for Elective Cranial Procedures With Dural Incision. Completed, enrolled 250 participants across 17 sites.

Detailed Summary

The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElective Cranial Procedures With Dural Incision
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.0 years ago

Interventions

Adherus Dural Sealantdevice

In situ polymerizing sealant