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DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)

This study is currently recruiting participants.
Verified June 2012 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01410864
First received: August 4, 2011
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Dural Sealing
 Device: DuraSeal Exact Spine Sealant System
Other: Control
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: DuraSeal Exact Spine Sealant System Post-Approval Study

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Post-operative CSF leaks [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-operative surgical site infections [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
    Deep surgical site infections as defined by the Center for Disease Control criteria.

  • Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1044
Study Start Date: August 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment
DuraSeal Exact Spinal Sealant System
 Device: DuraSeal Exact Spine Sealant System
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Retrospective Control Arm
Medical records will be retrospectively reviewed to identify cases where subjects who have undergone a previous spinal procedure where Standard of Care is administered for the treatment of either an intentional or incidental opening of the dura
 Other: Control
Devices or drugs used to seal the dura

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Prospective Treatment group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Retrospective Control group will be patients that have previously undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural)

Criteria

Inclusion Criteria (Prospective Treatment Arm):

  • Subject is 18 years of age or older
  • 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.
  • Subjects that have a dural opening/tear will be treated with DuraSeal. However, in some instances, there may be an occasion where the investigator chooses not to use DuraSeal due to a specific surgical reason.

Exclusion Criteria (Prospective Treatment Arm):

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

Inclusion Criteria (Retrospective Control Arm):

  • Subject is 18 years of age or older
  • Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred
  • Informed consent has been provided by the subject (if required by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria (Retrospective Control Arm):

  • Subject has received DuraSeal Sealant (either cranial or spinal) during the target procedure
  • Pregnant or breastfeeding females (as documented in the medical records)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410864

Contacts
Contact: Tracy Jennings, BS 781-839-1735 tracy.jennings@covidien.com
Contact: Sarah Kennedy, MS 619-325-9422 sarah.kennedy@covidien.com

Locations
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Covidien
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01410864     History of Changes
Other Study ID Numbers: COVDRSS0002
Study First Received: August 4, 2011
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
cerebrospinal fluid leaks
dural opening
dural sealing

ClinicalTrials.gov processed this record on June 13, 2013