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A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope (SECURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02530970
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : March 11, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

Brief Summary:
The objective of the SECURE Study is to actively gather additional information on the use of the CorMatrix® CanGaroo ECM® Envelope in a post market observational study.

Condition or disease
Cardiovascular Disease

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Study Type : Observational
Actual Enrollment : 1025 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope
Study Start Date : October 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018



Primary Outcome Measures :
  1. Proportion of Subjects With ECM Related Adverse Events [ Time Frame: Participants were followed for an average of 235.0 days. ]
    ECM related adverse events were collected at all study visits.

  2. Number of Participants With Major Pocket Infections [ Time Frame: Participants were followed for an average of 235.0 days. ]
    Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.
Criteria

Inclusion Criteria:

  • Subjects who have received CorMatrix® CanGaroo ECM® Envelope for an implantable electronic device placement.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530970


Locations
Show Show 39 study locations
Sponsors and Collaborators
Aziyo Biologics, Inc.
Investigators
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Study Director: Andrew Green CorMatrix Cardiovascular, Inc.
  Study Documents (Full-Text)

Documents provided by Aziyo Biologics, Inc.:
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Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT02530970    
Other Study ID Numbers: 14-PR-1110
First Posted: August 21, 2015    Key Record Dates
Results First Posted: March 11, 2020
Last Update Posted: March 24, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Cardiovascular Diseases