Recruiting

3D-Printed Prosthesis

Sponsor:

Mayo Clinic

Code:

NCT07047872

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computer-Aided Diagnosis

Prosthetics Intervention

Prosthetics Intervention

Prosthetics Intervention

Questionnaire Administration

Study Details

Brief summary:

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.

Conditions

Breast Carcinoma

Study ID

NCT07047872

Start date

Nov 5, 2024

Status verified date

Aug, 2026

Completion date

Nov 5, 2027

Anticipated

Primary completion date

Nov 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (3D-printed external breast prosthesis)

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.

Interventions

Computer-Aided Diagnosis

Undergo CAD development for patient-specific external breast prosthesis model

Prosthetics Intervention

Undergo measurements for external breast prosthesis

Prosthetics Intervention

Undergo fitting for 3D-printed external breast prosthesis

Prosthetics Intervention

Receive 3D-printed external breast prosthesis

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Patient-reported satisfaction with appearance [ Time Frame: At baseline, 1 month, 3 months, 6 months, and 1 year ]
  • Patient-reported emotional well-being [ Time Frame: At baseline, 1 month, 3 months, 6 months, and 1 year ]

Central Contacts and Locations

Central contacts

Aparna Vijayasekaran

507-538-1701vijayasekaran.aparna@mayo.edu

Nicole G. Sanchez Figueroa, MD, MS

507-538-6419sanchezfigueroa.nicole@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Nicole G. Sanchez Figueroa

507-538-6419sanchezfigueroa.nicole@mayo.edu

Clinical Trials G. Referral Office, MD, MS

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Aparna Vijayasekaran, MBBS

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-17.