Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556654
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Tissue Reinforcement for Breast Reconstruction TRBR Pivotal Clinical Study REDEFINE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Safety and Effectiveness of the GORE Tissue Reinforcement for Breast Reconstruction Device TRBR Device When Used in the Reinforcement of Breast Reconstruction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The GORE Tissue Reinforcement for Breast Reconstruction TRBR research study will look at breast reconstruction during mastectomy procedures There will be two arms in this study a Prospective Arm where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction TRBR Device and a Retrospective Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery This research study will look at the safety of the Study Device and the success of the participants breast reconstruction The Study Device is investigational which means it has not yet been used nor approved by the FDA for this treatment The data collected in this study will be compared to the data collected in the Retrospective Arm
Detailed Description:
None
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