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DuraSeal Exact Spine Sealant System Post-Approval Study

NCT01410864 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 924

Last updated 2017-03-01

No results posted yet for this study

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.

Conditions

  • Dural Sealing

Interventions

DEVICE

DuraSeal Exact Spine Sealant System

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

OTHER

Control

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

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

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 NCT01410864 on ClinicalTrials.gov