A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope

Withdrawn

• Conditions: Coronary Disease
• Interventions: Device: CorMatrix CanGaroo ECM Envelope

• Registration Number: NCT02418143
• Lead Sponsor: Aziyo Biologics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

1. Known sensitivities to porcine material.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Implantable electronic device placement	CorMatrix CanGaroo ECM Envelope	CorMatrix CanGaroo ECM envelope for an implantable electronic device placement following a battery change out or upgrade.

Primary Outcome Measures

Name	Time	Method
Device Related Adverse Events	1 day post-operative follow up visit