NCT07047872

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computer-Aided Diagnosis	Undergo CAD development for patient-specific external breast prosthesis model
PROCEDURE	Prosthetics Intervention	Undergo measurements for external breast prosthesis
PROCEDURE	Prosthetics Intervention	Undergo fitting for 3D-printed external breast prosthesis
PROCEDURE	Prosthetics Intervention	Receive 3D-printed external breast prosthesis
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-11-05
• Completion: 2026-11-05
• First posted: 2025-07-02
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States