A 3D-Printed External Breast Prosthesis For The Improvement Of Patient-reported Outcomes Among Breast Cancer Patients That Underwent A Mastectomy Without Reconstruction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-004692
NCT ID: NCT07047872
Sponsor Protocol Number: 24-004692
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Aparna Vijayasekaran, M.B.B.S. |
Closed for enrollment |
Contact information:
Nicole Sanchez Figueroa
(507) 538-6419
Contact Ussanchezfigueroa.nicole@mayo.edu
|
More information
Publications
Publications are currently not available