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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02418143
Other study ID # 15-PR-1169
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2015
Est. completion date February 2016

Study information

Verified date July 2023
Source Aziyo Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Device Related Adverse Events 1 day post-operative follow up visit
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