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

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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 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

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device Related Adverse Events
Time Frame: 1 day post-operative follow up visit
1 day post-operative follow up visit

Collaborators and Investigators

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

Sponsor

Aziyo Biologics, Inc.

Investigators

  • Study Director: Director, Clinical Development, Aziyo Biologics

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

September 1, 2015

Primary Completion (Estimated)

January 1, 2016

Study Completion (Estimated)

February 1, 2016

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimated)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-PR-1169

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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