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Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch (CIP-003)

NCT06088680 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-06-04

No results posted yet for this study

Summary

The overall purpose of this observational Post Market Clinical Follow Up (PMCF) study is to ensure continued acceptability of the benefit risk ratio by assessment of safety and performance, in patients undergoing cardiovascular repair or reconstruction surgery under standard clinical care with the commercially available Glycar Pericardial Patch.

Conditions

  • Cardiac Defect
  • Cardiac Anomaly
  • Pericardial Defect

Interventions

DEVICE

Glycar Pericardial Patch

Glycar Bovine pericardial patch with AldeCaptm Technology (aka SJM with EnCaptm technology)

Sponsors & Collaborators

  • GLYCAR SA (Pty) Ltd

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2024-06-03
Completion
2024-06-03

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088680 on ClinicalTrials.gov