Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)
NCT ID: NCT06088680
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2023-09-26
2024-06-03
Brief Summary
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Detailed Description
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This real-world evidence retrospective data collection single-arm multicentre, observational, non-interventional study will enrol up to a minimum of 50 consecutive participants who meet inclusion criteria, in 2-3 centres. The study is aimed at providing real-world evidence of the Glycar Pericardial patch.
Retrospective data analysis will include collected clinical data from consecutive participants with a minimum of 2 years follow up, meaning from 30 June 2020 and going back in time. The quality of medical history being recorded is believed to be more reliable and complete in the most recent years. Therefore, it was decided to start enrolling consecutive participants in a reverse chronological order.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Open Label- Glycar Pericardial Patch
patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.
Glycar Pericardial Patch
Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)
Interventions
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Glycar Pericardial Patch
Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)
Eligibility Criteria
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Inclusion Criteria
* Participant has undergone a cardiac or vascular procedure which falls within the indications for use and required the use of Glycar Pericardial Patch
ALL
No
Sponsors
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GLYCAR SA (Pty) Ltd
INDUSTRY
Responsible Party
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Locations
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Red Cross War Memorial Children's Hospital
Cape Town, Rondebosch, South Africa
Countries
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Other Identifiers
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CIP-003
Identifier Type: -
Identifier Source: org_study_id
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