RecruitingNot ApplicableNCT07047872

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

Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses

Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Adult individuals aged 18 years or older
History of unilateral or bilateral mastectomy for any indication
No implant or autologous reconstruction
Allowed: Goldilocks closure, flat closure, simple skin closure
Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
Ability to provide informed consent
Ability to complete study procedures, including surface scanning (with temporary fiducial skin markers), standardized photography, and surveys at 1, 3, 6, and 12 months

Exclusion Criteria5

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)
Patients with open wounds, active infection, or dermatologic conditions at the chest/breast site that would interfere with scanning, fiducial marker placement, or prosthesis use
Patients unwilling or unable to undergo surface scanning, standardized photography, or complete survey follow-up