Personalized 3D-printed external breast prosthesis after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional project uses 3D surface scanning and computer-aided design to create patient-specific external breast prostheses that are manufactured with 3D printing. Adults who have had unilateral or bilateral mastectomy without implant or autologous reconstruction undergo surface scanning (with temporary fiducial skin markers), standardized photography, and receive a customized prosthesis. Patient-reported outcome questionnaires are collected at baseline and at 1, 3, 6, and 12 months to measure comfort, fit, and quality of life. The goal is to determine whether a better-fitting, personalized external prosthesis leads to improved self-reported outcomes over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Aparna Vijayasekaran, MBBS — Mayo Clinic
• Study coordinator: Aparna Vijayasekaran
• Email: vijayasekaran.aparna@mayo.edu
• Phone: 507-538-1701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.