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NCT07047872 | RECRUITING | Breast Carcinoma

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

Mayo Clinic

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.

Condition or disease

Breast Carcinoma

Intervention/treatment

Computer-Aided Diagnosis

Prosthetics Intervention

Prosthetics Intervention

Prosthetics Intervention

Questionnaire Administration

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
Actual Study Start Date : 2024-11-05
Estimated Primary Completion Date : 2026-11-05
Estimated Study Completion Date : 2026-11-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adult individuals aged 18 years or older
  • * Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction
  • * Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses
  • * Ability to provide informed consent
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)
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction

Location Details

NCT07047872

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905