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Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures

NCT01158378 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2014-04-08

Study results available
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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.

Conditions

  • Elective Cranial Procedures With Dural Incision

Interventions

DEVICE

Adherus Dural Sealant

In situ polymerizing sealant

Sponsors & Collaborators

  • HyperBranch Medical Technology, Inc

    lead INDUSTRY

Principal Investigators

  • Mark Smith, MD · Carolina Neurosurgery & Spine Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158378 on ClinicalTrials.gov