Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult individuals aged 18 years or older

• Have undergone mastectomy for breast cancer treatment without subsequent breast reconstruction

• Willingness to participate in the study by completing PRO assessments or receiving personalized 3D-printed breast prostheses

• Ability to provide informed consent

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Aparna Vijayasekaran
vijayasekaran.aparna@mayo.edu
507-538-1701
Backup
Nicole G. Sanchez Figueroa, MD, MS
sanchezfigueroa.nicole@mayo.edu
507-538-6419
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2026-11-05
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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