Coronary DiseaseJUMPNCT02418143
A Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
An observational study of Coronary Disease, run by Elutia Inc..
Trial summary
Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- What is being tested?
- CorMatrix CanGaroo ECM Envelope
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
- Signed Informed Consent
Who cannot join
- 1. Known sensitivities to porcine material.
About this study
Official title: 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.
- Conditions
- Coronary Disease
- Being tested
- CorMatrix CanGaroo ECM Envelope
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorMatrix CanGaroo ECM EnvelopeDevice
Subjects who have received CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change or upgrade.
| Study group | Role | What they receive |
|---|---|---|
| Implantable electronic device placement | CorMatrix CanGaroo ECM envelope for an implantable electronic device placement following a battery change out or upgrade. Receives: Device: CorMatrix CanGaroo ECM Envelope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Related Adverse Events
Measured: 1 day post-operative follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Clinical Development, Study director, Aziyo Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418143
- Sponsor's protocol ID
- 15-PR-1169
- Acronym
- JUMP
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix® CanGaroo ECM® Envelope
- ClinicalTrials.gov ID
- NCT02418143
- Acronym / sponsor ID
- JUMP / 15-PR-1169
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Actively gather additional information on the use of CorMatrix CanGaroo ECM Envelope in a post market observational study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable electronic device placement | – | Device: CorMatrix CanGaroo ECM EnvelopeCorMatrix CanGaroo ECM envelope for an implantable electronic device placement following a battery change out or upgrade. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Subject who has received the CorMatrix CanGaroo ECM Envelope for an implantable electronic device following battery change out or upgrade.
- Signed Informed Consent
Key exclusion criteria (1 listed)
- 1. Known sensitivities to porcine material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorMatrix CanGaroo ECM EnvelopeSubjects who have received CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change or upgrade. | Device | Implantable electronic device placement |
Primary outcome
Device Related Adverse Events
Time frame: 1 day post-operative follow up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Clinical Development study director
Aziyo Biologics
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Elutia Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Related Adverse Events (time frame: 1 day post-operative follow up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.