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

This study is currently recruiting participants.
Verified November 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01410864
First received: August 4, 2011
Last updated: November 6, 2013
Last verified: November 2013

August 4, 2011
November 6, 2013
August 2011
December 2016   (final data collection date for primary outcome measure)
Post-operative CSF leaks [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01410864 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
DuraSeal Exact Spine Sealant System Post-Approval Study
DuraSeal Exact Spine Sealant System Post-Approval Study

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.

Not Provided
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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)

Dural Sealing
  • 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
  • Treatment
    DuraSeal Exact Spinal Sealant System
    Intervention: Device: DuraSeal Exact Spine Sealant System
  • 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
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1044
December 2016
December 2016   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Stefani Battaglia 781-577-5912 stefani.battaglia@covidien.com
Contact: Noreen Fahey 203-821-4716 noreen.fahey@covidien.com
United States
 
NCT01410864
COVDRSS0002
No
Covidien
Covidien
Not Provided
Not Provided
Covidien
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP