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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07047872
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computer-Aided Diagnosis — PROCEDURE
    Undergo CAD development for patient-specific external breast prosthesis model
  • Prosthetics Intervention — PROCEDURE
    Undergo measurements for external breast prosthesis
  • Prosthetics Intervention — PROCEDURE
    Undergo fitting for 3D-printed external breast prosthesis
  • Prosthetics Intervention — PROCEDURE
    Receive 3D-printed external breast prosthesis
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Nov 5, 2024
Status verified
Dec 2025
Primary completion
Nov 5, 2026
Completion
Nov 5, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.

Primary Outcome Measure

Patient-reported satisfaction with appearance [ Time Frame: At baseline, 1 month, 3 months, 6 months, and 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Nicole G. Sanchez Figueroa
[email protected]
507-538-6419
Clinical Trials G. Referral Office, MD, MS
[email protected]
855-776-0015
Aparna Vijayasekaran, MBBS (PRINCIPAL_INVESTIGATOR)
Sandhya Pruthi, MD (PRINCIPAL_INVESTIGATOR)
Nicole G. Sanchez Figueroa, MD, MS (SUB_INVESTIGATOR)
Amy C. Degnim, MD (SUB_INVESTIGATOR)
Megan L. Loghry (SUB_INVESTIGATOR)
Johnathan M. Morris, MD (SUB_INVESTIGATOR)
Victoria A. Sears, MS (SUB_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic in Rochester· Rochester, MN

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