A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction

{ "3D-Printed External Breast Prosthesis for Mastectomy Patients", "This study is looking at whether a custom-made, 3D-printed external breast prosthesis can improve how women feel about their appearance and emotional well-being after a mastectomy (surgical removal of the breast) without reconstruction. Traditional external breast prostheses, which are worn on the outside of the body, can sometimes be uncomfortable or not fit well. This study will involve creating a personalized 3D-printed prosthesis for you. We are looking for adults aged 18 or older who have had a mastectomy and have not had breast reconstruction. Your satisfaction with your appearance and emotional well-being will be measured over one year. The study aims to enroll 50 participants.", "design": "This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.", "commitments": "You would undergo measurements and fittings for a 3D-printed external breast prosthesis, receive the prosthesis, and complete questionnaires at baseline, 1 month, 3 months, 6 months, and 1 year.", "compensation": "Not stated in the trial record.", "follow_up": "You would be followed for one year after receiving the prosthesis, with assessments at 1 month, 3 months, 6 months, and 1 year.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07047872

A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~50 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Computer-Aided DiagnosisProsthetics InterventionQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-reported satisfaction with appearance
Measured over At baseline, 1 month, 3 months, 6 months, and 1 year
+1 more outcome measured
Breast Carcinoma
1 sites across 1 states
Minnesota1
  • Aparna Vijayasekaran, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Sandhya Pruthi, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Patient-reported satisfaction with appearanceAt baseline, 1 month, 3 months, 6 months, and 1 year

    Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.

  • Patient-reported emotional well-beingAt baseline, 1 month, 3 months, 6 months, and 1 year

    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.