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

Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a custom, 3D-printed breast form worn outside the body to replace a removed breast. It looks at whether the form improves how patients report feeling. The study is for adults who had one or both breasts removed and did not have surgery to rebuild them with implants or body tissue.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You had one or both breasts removed for any reason.
  • You did not have a breast rebuilt with an implant or body tissue. Goldilocks closure, which shapes leftover skin and fat, flat closure, and simple skin closure are allowed.
  • You are willing to take part by answering surveys about how you feel or receiving custom 3D-printed breast forms.
  • You can understand the study and agree to take part.
  • You can complete body surface scans with temporary skin markers, study photos, and surveys at 1, 3, 6, and 12 months.

Who can't join

  • You have a health condition, such as a severe illness, that could prevent you from completing study steps.
  • You are unwilling or unable to understand the study and agree to take part.
  • You cannot communicate well enough in the study language, such as English.
  • You have open wounds, an active infection, or skin problems on your chest or breast that would interfere with scans, skin markers, or wearing the breast form.
  • You are unwilling or unable to have body surface scans, have study photos taken, or complete follow-up surveys.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MN