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NCT Number: NCT07047872

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

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.

Recruiting

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Aided Diagnosis

Procedure

Undergo CAD development for patient-specific external breast prosthesis model

Other names: CAD

Prosthetics Intervention

Procedure

Undergo measurements for external breast prosthesis

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Patient-reported satisfaction with appearance

    Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.

  2. Patient-reported emotional well-being

    Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by a an Emotional Response survey, which consists of 12 questions answered on a five-point Likert scale ranging from strongly disagree to strongly agree.

Secondary outcomes

  1. Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis

    Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.

  2. Patient-reported fit of personalized 3D-printed breast prosthesis

    Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.

  3. Patient-reported satisfaction with personalized 3D-printed breast prosthesis

    Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by a Prostheses Evaluation survey, which consists of 11 questions answered on a five-point Likert scale ranging from very dissatisfied to very satisfied.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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