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

NCT07047872 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-09

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Aparna Vijayasekaran, MBBS · Mayo Clinic

  • Sandhya Pruthi, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-05
Primary Completion
2026-11-05
Completion
2026-11-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047872 on ClinicalTrials.gov