3D-Printed Breast Prosthesis for Mastectomy Patients
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
50 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for women who have had a mastectomy without reconstruction. Participants will receive a personalized 3D-printed breast prosthesis and provide feedback about their experience.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have had a mastectomy
I have not had breast reconstruction
I can consent to participate in this study
I am willing to take part in assessments and receive the prosthesis
I can complete required study tasks like surveys and scanning
You may not be able to join if
I have severe medical conditions that could affect my participation
I cannot provide informed consent
I cannot communicate effectively in English
I have open wounds or infections on my chest
I am not willing or able to participate in scanning or photography
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
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…
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
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