Breast Carcinoma / Questionnaire Administration / Prosthetics Intervention · Interventional Study

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective single-arm trial, currently recruiting, designed to evaluate whether 3D-printed customized external breast prostheses improve patient-reported satisfaction with appearance and emotional well-being in post-mastectomy patients who decline or are ineligible for surgical reconstruction. No results have been posted in this registry record; the study remains in early-phase evaluation of a novel medical device intervention.

What was studied

Interventional, Single Group, Open label, Supportive Care purpose. Breast Carcinoma; age from 18 Years. Intervention: Supportive care (3D-printed external breast prosthesis). n = 50. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results from this trial are not yet available. Once completed, outcomes on patient satisfaction and emotional well-being with 3D-printed prostheses could inform counselling and device options for post-mastectomy patients, but the single-arm design and small sample limit generalizability pending peer-reviewed publication.

Plain-language summary

This is an active recruiting trial with no results reported; it is a feasibility and patient-reported outcome study in a small population with surrogate endpoints.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Patient-reported satisfaction with appearance (assessed at At baseline, 1 month, 3 months, 6 months, and 1 year); Patient-reported emotional well-being (assessed at At baseline, 1 month, 3 months, 6 months, and 1 year)

DesignInterventional, Single Group, Open label, Supportive Care purpose

PopulationBreast Carcinoma; age from 18 Years

Sample size50

InterventionSupportive care (3D-printed external breast prosthesis)

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment50

Primary outcome measure 1Patient-reported satisfaction with appearance at baseline, 1 month, 3 months, 6 months, and 1 year

Primary outcome measure 2Patient-reported emotional well-being at baseline, 1 month, 3 months, 6 months, and 1 year

Clinical bottom line

Caveats

This is a registry record only; no results have been posted or peer-reviewed.
Single-arm design with no control or comparator arm; cannot establish superiority or comparative benefit.
Planned enrollment is modest (n=50); power and precision of estimates unknown.
Phase designation listed as 'NA'; device development stage and regulatory classification not described in registry text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm interventional study; no control group described in registry record.

Directness

moderate

Measures patient-reported satisfaction and emotional well-being directly in target population.

Consistency

insufficient

No results posted; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

No blinding or comparator described; risk of bias cannot be evaluated pre-results.

Sample adequacy

limited

Estimated enrollment 50 participants; modest sample for robust PRO conclusions.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07047872). This is a study registration, not published results. Lead sponsor: Mayo Clinic. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Breast Carcinoma. Interventions: PROCEDURE: Computer-Aided Diagnosis; PROCEDURE: Prosthetics Intervention; PROCEDURE: Prosthetics Intervention; PROCEDURE: Prosthetics Intervention; OTHER: Questionnaire Administration. Primary outcome measures: Patient-reported satisfaction with appearance , At baseline, 1 month, 3 months, 6 months, and 1 year; Patient-reported emotional well-being , At baseline, 1 month, 3 months, 6 months, and 1 year. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07047872Breast CarcinomaMayo ClinicQuestionnaire AdministrationProsthetics InterventionComputer-Aided Diagnosis