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Trial record 1 of 1 for:    SECURE Cormatrix
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A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope (SECURE)

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ClinicalTrials.gov Identifier: NCT02530970
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : August 17, 2018
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

Study Type : Observational
Actual Enrollment : 1025 participants
Observational Model: Case-Only
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. 1. The proportion of subjects with CorMatrix CanGaroo ECM related adverse events. [ Time Frame: Participants will be followed for an expected average of 3 months. ]
    Device related adverse events

  2. 2. The incidence of major pocket infection. [ Time Frame: Participants will be followed for an expected average of 3 months. ]
    Major Infection



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


  Show 39 Study Locations
Sponsors and Collaborators
Aziyo Biologics, Inc.
Investigators
Study Director: Andrew Green CorMatrix Cardiovascular, Inc.

Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT02530970     History of Changes
Other Study ID Numbers: 14-PR-1110
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Cardiovascular Diseases