Personalized 3D-printed external breast prosthesis after mastectomy
Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
This trial will try a custom 3D-printed external breast prosthesis to see if it improves patient-reported outcomes for people who had a mastectomy and did not have reconstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07047872 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older who have had unilateral or bilateral mastectomy without implant or autologous reconstruction, can provide informed consent, complete surface scanning and standardized photography, and complete follow-up surveys are ideal candidates.
Not a fit: Patients with implant or autologous reconstruction, active chest wounds or infections, inability to communicate in the study language, or inability to attend required scans and follow-up visits are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, patients may experience better comfort, fit, body image, and overall quality of life from a customized external breast prosthesis.
How similar studies have performed: Small feasibility reports and pilot projects of custom or 3D-printed external prostheses have reported improved fit and patient satisfaction, but large controlled trials are limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.