A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction

Launched by MAYO CLINIC · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of breast prosthesis, made using 3D printing technology, can help improve the comfort and satisfaction of women who have had a breast removed due to cancer but chose not to have breast reconstruction surgery. Unlike traditional prostheses, this 3D-printed prosthesis is customized to fit each person’s body using detailed imaging and computer design, which may lead to a better fit and feel.

Women aged 18 and older who have had a mastectomy (surgical removal of the breast) for breast cancer but did not have reconstruction may be eligible to join. Participants will be asked to use the 3D-printed prosthesis and share their experiences through surveys about comfort, fit, and overall satisfaction. The goal is to see if this personalized approach can improve how patients feel after surgery. If you have had a mastectomy and are interested in a potentially more comfortable and better-fitting breast prosthesis, this study might be a good option to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult individuals aged 18 years or older
• • Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction
• • Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
• • Ability to provide informed consent
• Exclusion Criteria:
• • Individuals with contraindications for participation, such as severe medical conditions that may interfere with study procedures
• • Lack of willingness or capacity to provide informed consent for study participation
• • Inability to communicate effectively in the study language (e.g., English)