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A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
Sponsor: Mayo Clinic
Summary
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy) without surgical reconstruction. Breast cancer remains a significant health concern and often requires a mastectomy. While breast reconstruction is a common option following a mastectomy, some patients decide not to undergo it or are not candidates. An external breast prosthesis is worn on the outside of the body to replace the breast that was removed during the mastectomy. Traditional external breast prostheses may lack comfort and fit. A 3D-printed external breast prosthesis is customized to the patient using 3D imaging along with computer-aided design (CAD) to interpret the 3D imaging to develop and print a patient-specific external breast prosthesis. This may create a better fitting prosthesis which may improve PRO.
Official title: Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-11-05
Completion Date
2026-11-05
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Computer-Aided Diagnosis
Undergo CAD development for patient-specific external breast prosthesis model
Prosthetics Intervention
Undergo measurements for external breast prosthesis
Prosthetics Intervention
Undergo fitting for 3D-printed external breast prosthesis
Prosthetics Intervention
Receive 3D-printed external breast prosthesis
Questionnaire Administration
Ancillary studies
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States