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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2026-11-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (3D-printed external breast prosthesis)

Patients undergo CT, development of a patient-specific external breast prosthesis model using CAD, and measurements for 3D-printed external breast prosthesis during screening. Patients then undergo fitting for and receive the 3D-printed external breast prosthesis on study.

Group Type EXPERIMENTAL

Computer-Aided Diagnosis

Intervention Type PROCEDURE

Undergo CAD development for patient-specific external breast prosthesis model

Prosthetics Intervention

Intervention Type PROCEDURE

Undergo measurements for external breast prosthesis

Prosthetics Intervention

Intervention Type PROCEDURE

Undergo fitting for 3D-printed external breast prosthesis

Prosthetics Intervention

Intervention Type PROCEDURE

Receive 3D-printed external breast prosthesis

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Computer-Aided Diagnosis

Undergo CAD development for patient-specific external breast prosthesis model

Intervention Type PROCEDURE

Prosthetics Intervention

Undergo measurements for external breast prosthesis

Intervention Type PROCEDURE

Prosthetics Intervention

Undergo fitting for 3D-printed external breast prosthesis

Intervention Type PROCEDURE

Prosthetics Intervention

Receive 3D-printed external breast prosthesis

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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CAD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No