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

July 19, 2023 updated by: Aziyo Biologics, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1025

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Advanced Cardiovascular, LLC
    • Arizona
      • Chandler, Arizona, United States, 85286
        • Heart & Rhythm Solution
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart Rhythm Center
      • Phoenix, Arizona, United States, 85006
        • Cardiac Electrophysiology/St. Joseph
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock VA Clinic
      • Rogers, Arkansas, United States, 72758
        • Mercy Heart & Vascular
    • California
      • Stockton, California, United States, 95204
        • Stockton Medical Center
      • Tustin, California, United States, 92780
        • St. Joseph Heritage Medical Group
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA
      • Delray Beach, Florida, United States, 33484
        • Bethesda
      • Fort Lauderdale, Florida, United States, 33308
        • Florida Heart & Rhythm Specialists
      • Jacksonville, Florida, United States, 32209
        • UF Health Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Baptist Heart Specialists
      • Panama City, Florida, United States, 32401
        • Cardiovascular Institute of NW Florida
      • Pensacola, Florida, United States, 32501
        • Baptist Healthcare Cardiology
    • Georgia
      • Albany, Georgia, United States, 31701
        • Cardiology Associates
      • Athens, Georgia, United States, 30606
        • Athens Cardiology Group
      • Gainesville, Georgia, United States, 30501
        • North Georgia Heart Foundation
      • Macon, Georgia, United States, 31201
        • Georgia Arrhythmia Consultants
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University Physician Group
      • Detroit, Michigan, United States, 48236
        • St. John Providence
      • Flint, Michigan, United States, 48507
        • Cardiology Institute of Michigan
      • Flushing, Michigan, United States, 48433
        • Advanced Cardiovascular Clinic
      • Lansing, Michigan, United States, 48912
        • Sparrow Thoracic Cardiovascular Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • HeartPlus Center
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Sanger Heart & Vascular
      • New Bern, North Carolina, United States, 28562
        • Carolina East Heart Center
      • Raleigh, North Carolina, United States, 27610
        • NC Heart & Vascular
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Winston-Salem Cardiology
    • Oregon
      • Portland, Oregon, United States, 97239
        • University of Oregon Health Science Center
    • Pennsylvania
      • York, Pennsylvania, United States, 17405
        • WellSpan Heart & Vascular
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Arrhythmia Specialists
      • Columbia, South Carolina, United States, 29204
        • South Carolina Heart Center
      • Lancaster, South Carolina, United States, 29720
        • Carolina Heart Specialists
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Cardiology Clinical Research
    • Texas
      • The Woodlands, Texas, United States, 77384
        • UT Health Science Center - EP Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Participants were followed for an average of 235.0 days.
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.
Participants were followed for an average of 235.0 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aziyo Biologics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrew Green, CorMatrix Cardiovascular, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-PR-1110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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