Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088680
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2023-10-02
Brief Title:
Post Market Observational Retrospective Study of Glycar Bovine Pericardial Patch CIP-003
Sponsor:
GLYCAR SA Pty Ltd
Organization:
GLYCAR SA Pty Ltd
Study Overview
Official Title:
A Post Market Multicentre Retrospective Study of Glycar Bovine Pericardial Patch With AldeCaptm Technology Aka SJM With EnCaptm Technology in Cardiac and Vascular Repair or Reconstruction Surgery CIP-003
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
To comply with Medical Device Regulation MDR Post Market Clinical Follow Up PMCF requirements through proactive ongoing assessment of the safety efficacy and performance of the commercially available Glycar Pericardial Patch in patients undergoing cardiovascular repair or reconstruction surgery
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None