An interventional study of Computer-Aided Diagnosis and Prosthetics Intervention in Breast Carcinoma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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No implant or autologous reconstruction
Exclusion Criteria:
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 · Procedure: Prosthetics Intervention · Other: Questionnaire Administration
Undergo CAD development for patient-specific external breast prosthesis model
Also known as: CAD
Undergo measurements for external breast prosthesis
Undergo fitting for 3D-printed external breast prosthesis
Receive 3D-printed external breast prosthesis
Ancillary studies
Patient-reported satisfaction with appearance
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported emotional well-being
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported comfort of personalized three-dimensional (3D)-printed breast prosthesis
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported fit of personalized 3D-printed breast prosthesis
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Patient-reported satisfaction with personalized 3D-printed breast prosthesis
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.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Plan to share: No
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