DuraSeal Exact Spine Sealant System Post-Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01410864

Acronym

DuraSeal PAS

Enrollment

924

Registered

2011-08-05

Start date

2011-08-31

Completion date

2016-07-31

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dural Sealing

Keywords

cerebrospinal fluid leaks, dural opening, dural sealing

Brief summary

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.

Interventions

DEVICEDuraSeal Exact Spine Sealant System

DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.

OTHERControl

Devices or drugs used to seal the dura (other than DuraSeal)

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
Post-operative CSF leaks	90 days post-operative

Secondary

Measure	Time frame	Description
Post-operative surgical site infections	90 days post-operative	Deep surgical site infections as defined by the Center for Disease Control criteria.
Post-operative neurological serious adverse events	90 days post-operative	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026