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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01158378

Public ClinicalTrials.gov record NCT01158378. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 5, 2026, 2:42 AM EST

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01158378
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
250 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2010 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Jan 2013 (Actual)
Last update posted
Apr 8, 2014

2010 – 2013

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Colorado Brain and Spine Institute/Swedish Medical Center Englewood Colorado 80113 —
Florida Hospital Orlando Florida 32804 —
University of South Florida Tampa Florida 33606 —
Northwestern University Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
NorthShore University HealthSystem Evanston Illinois 60201 —
Wayne State University Detroit Michigan 48201 —
Borgess Research Institute Kalamazoo Michigan 49048 —
Saint Louis University St Louis Missouri 63104 —
Stony Brook University Medical Center Stony Brook New York 11794-8122 —
Carolina Neurosurgery & Spine Associates Charlotte North Carolina 28204 —
Wake Forest School of Medicine Winston-Salem North Carolina 27157-1029 —
Mayfield Clinic Cincinnati Ohio 45219 —
Oklahoma Spine and Brain Institute Tulsa Oklahoma 74132 —
Penn State University Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850 —
University of Virginia Charlottesville Virginia 22903 —
West Virginia University Morgantown West Virginia 26506-9183 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01158378, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 8, 2014 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01158378 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →