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RECRUITING
NCT07047872
NA

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

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States