- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418143
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Withdrawn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:
- Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
- 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.
|
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
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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