Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584396
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks the EMPOWER Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EMPOwER Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy
Detailed Description:
PRIMARY OBJECTIVE
I Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction
OUTLINE This is an observational study
Patients undergo tissue collection during standard of care surgery have their medical records reviewed and complete questionnaires throughout the study
I Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction
OUTLINE This is an observational study
Patients undergo tissue collection during standard of care surgery have their medical records reviewed and complete questionnaires throughout the study
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