Trial record 8 of 9 for:    "Cerebrospinal fluid leak"

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
  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

Resource links provided by NLM:


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: December 2016
Estimated Primary Completion Date: December 2016 (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: Stefani Battaglia 781-577-5912 stefani.battaglia@covidien.com
Contact: Noreen Fahey 203-821-4716 noreen.fahey@covidien.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90033
Recruiting
Sacramento, California, United States, 95616
United States, Colorado
Recruiting
Boulder, Colorado, United States, 80302
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20037
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63130
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States, 03766
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45219
Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29406
United States, Texas
Recruiting
Plano, Texas, United States, 75093
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: November 6, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014