NCT07047872 A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
| NCT ID | NCT07047872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2026-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-11-05 with a primary completion date of 2026-11-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Aparna Vijayasekaran, MBBS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07047872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07047872 currently recruiting?
Yes, NCT07047872 is actively recruiting participants. Contact the research team at vijayasekaran.aparna@mayo.edu for enrollment information.
Where is the NCT07047872 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07047872 clinical trial?
NCT07047872 is sponsored by Mayo Clinic. The principal investigator is Aparna Vijayasekaran, MBBS at Mayo Clinic. The trial plans to enroll 50 participants.