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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 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) - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Supportive care (3D-printed external breast prosthesis) 		Patients undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis during screening. Patients then undergo fitting for and receive the 3D-printed external breast prosthesis on study.
  • Procedure: Computer-Aided Diagnosis
    Undergo CAD development for patient-specific external breast prosthesis model
    Other names:
    • CAD
  • 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

Recruiting Locations

Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Nicole G. Sanchez Figueroa
507-538-6419
sanchezfigueroa.nicole@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Aparna Vijayasekaran
507-538-1701
vijayasekaran.aparna@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.