DuraSeal Exact Spine Sealant System Post-Approval Study
NCT ID: NCT01410864
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
924 participants
OBSERVATIONAL
2011-08-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
NCT04086550
Study to Evaluate Safety and Effectiveness of Spinal Sealant
NCT00594035
Adherus™ Dural Sealant in Spinal Procedures
NCT04498026
Use of Spinal Sealant System During Spinal Surgery
NCT00458354
Post-market Assessment of Biodesign Dural Repair Grafts
NCT04057157
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DuraSeal Arm
Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
DuraSeal Exact Spine Sealant System
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Control Arm
Subjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening)
Control
Devices or drugs used to seal the dura (other than DuraSeal)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DuraSeal Exact Spine Sealant System
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Control
Devices or drugs used to seal the dura (other than DuraSeal)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
* DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
* Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)
* Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
* Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
* Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.
Exclusion Criteria
* Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Jose, California, United States
Stanford, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
East Syracuse, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Bend, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Plano, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COVDRSS0002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.