NCT Number: NCT07047872
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Amy C. Degnim, MD
SUB_INVESTIGATOR
Aparna Vijayasekaran, MBBS
PRINCIPAL_INVESTIGATOR
Clinical Trials G. Referral Office, MD, MS
CONTACT
Johnathan M. Morris, MD
SUB_INVESTIGATOR
Megan L. Loghry
SUB_INVESTIGATOR
Nicole G. Sanchez Figueroa
CONTACT
Nicole G. Sanchez Figueroa, MD, MS
SUB_INVESTIGATOR
Sandhya Pruthi, MD
PRINCIPAL_INVESTIGATOR
Victoria A. Sears, MS
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo CAD development for patient-specific external breast prosthesis model
Other names: CAD
Undergo measurements for external breast prosthesis
Ancillary studies
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by patient self-reported satisfaction with appearance and evaluated descriptively.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by a an Emotional Response survey, which consists of 12 questions answered on a five-point Likert scale ranging from strongly disagree to strongly agree.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by patient response on a 5-point Likert scale ranging from very dissatisfied to very satisfied.
Time frame: At baseline, 1 month, 3 months, 6 months, and 1 year
Will be assessed by a Prostheses Evaluation survey, which consists of 11 questions answered on a five-point Likert scale ranging from very dissatisfied to very satisfied.
Contact information is provided by the study sponsor or research team.
Aparna Vijayasekaran
CONTACT
Nicole G. Sanchez Figueroa, MD, MS
CONTACT
Mayo Clinic
Other
Patient Reported Outcomes Post-Mastectomy and In-house 3D-printed Individualized External Breast Prostheses
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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