Trial Search Results

DuraSeal Exact Spine Sealant System Post-Approval Study

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Integra LifeSciences Corporation

Stanford Investigator(s):

Intervention(s):

  • Device: DuraSeal Exact Spine Sealant System
  • Other: Control

Eligibility


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:

      - DuraSealâ„¢ Exact Spine Sealant (DuraSealâ„¢ Sealant group ONLY) OR

      - Any other method of sealing the dura with the exception of DuraSealâ„¢ 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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting