Status:
ACTIVE_NOT_RECRUITING
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Artidis
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
18+ years
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- \* Age 18 and older
- Female sex
- Patient with history of mastectomy with tissue expander placement
- Tissue expander in place at time of study enrollment
- Patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent
- Ability to understand and provide written informed consent in accordance with institutional policies
Exclusion
Key Trial Info
Start Date :
September 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06584396
Start Date
September 20 2023
End Date
August 30 2027
Last Update
September 18 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030