Actively Recruiting
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
Led by Mayo Clinic · Updated on 2025-12-09
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult individuals aged 18 years or older
- History of unilateral or bilateral mastectomy for any indication
- No implant or autologous reconstruction (goldilocks closure, flat closure, or simple skin closure allowed)
- Willingness to participate by completing patient-reported outcome assessments or receiving personalized 3D-printed prostheses
- Ability to provide informed consent
- Ability to complete study procedures including surface scanning with temporary skin markers, standardized photography, and surveys at 1, 3, 6, and 12 months
You will not qualify if you...
- Severe medical conditions that interfere with study procedures
- Unwillingness or inability to provide informed consent
- Inability to communicate effectively in the study language
- Open wounds, active infection, or skin conditions on chest/breast interfering with scanning, marker placement, or prosthesis use
- Unwillingness or inability to undergo surface scanning, photography, or complete survey follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Aparna Vijayasekaran
CONTACT
N
Nicole G. Sanchez Figueroa, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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