NCT02418143

Brief Summary

Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

April 9, 2015

Last Update Submit

July 19, 2023

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (1)

  • Device Related Adverse Events

    1 day post-operative follow up visit

Study Arms (1)

Implantable electronic device placement

CorMatrix CanGaroo ECM envelope for an implantable electronic device placement following a battery change out or upgrade.

Device: CorMatrix CanGaroo ECM Envelope

Interventions

CorMatrix CanGaroo ECM EnvelopeDEVICE

Subjects who have received CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change or upgrade.

Implantable electronic device placement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of any subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change out or upgrade.

You may qualify if:

  • Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
  • Signed Informed Consent

You may not qualify if:

  • \. Known sensitivities to porcine material.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Director, Clinical Development

    Aziyo Biologics

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 16, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

July 20, 2023

Record last verified: 2023-07