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OpenTrials
Completed

NCT Number: NCT02530970

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Cardiovascular, LLC, Alexander City, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope

Acronym: SECURE

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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