DuraSeal Exact Spine Sealant System Post-Approval Study

Completed

Conditions studied: Dural Sealing

In brief

This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Key facts

Study ID

NCT01410864

Run by

Integra LifeSciences Corporation

People needed

924

Starts

2011-08-01

Expected to finish

2016-07-01

Last updated by the study team

2017-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years of age or older
• 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.

You may not qualify if…

• The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
• Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — San Jose, California, United States
• Study site — Stanford, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Royal Oak, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — East Syracuse, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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