Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511167
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Post-market Surveillance Study to Evalute the Quality of Life and the Safety and Effectivness of the TIGR Matrix After Reconstructive Breast Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
National Prospective Multicentre Post Market Surveillance Study on Patient Reported Outcome of Implant Based Primary or Secondary Reconstructive Breast Surgery After Mastectomy Using the Complete Resorbable Synthetic TIGR Matrix
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIGR-Matrix
Brief Summary:
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery This will be done using the BREAST-Q questionnaire The study also aims to demonstrate that the fully resorbable TIGR Matrix is safe and effective
Detailed Description:
This national multicentre prospective non-randomized post market surveillance clinical device investigation will be performed to obtain information on the resorbable surgical mesh TIGR Matrix used during an implant-based breast surgery Data will be collected on the participants quality of life as well as on the rate of complications of the device under investigation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None