Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis.

NACompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

January 28, 2021

Primary Completion Date

October 24, 2024

Study Completion Date

October 24, 2024

Conditions
Breast Cancer
Interventions
DEVICE

MEAVANTI prothesis

"The experimental prosthesis is the MEAVANTI prosthesis (custom-made non-adherent prosthesis in silicone) which can be calibrated to 5 grams near the breast that remains after a mastectomy to create a visual symmetry but also a weight symmetry.~This prosthesis takes into account the curve of the breasts and the morphological details such as: skin color of the patients, size of the nipples, height of the nipples, shape of the breast.~The measurements of the patients will be taken using a 3D scanner (i.e. a scanner that corresponds to a 3d scanning and acquiring device (images), not irradiating), a scale and a colour chart."

DEVICE

Standard prothesis

This prosthesis will be compared with a standard non-adherent prosthesis (class I, silicone and polyurethane film), among the models available in the three ranges of standard prostheses (Amoena, Anita and Thuasne). The brand and model will be left to the patient's choice.

Trial Locations (1)

31059

CHU Rangueil, Toulouse

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT03981263 - Quality of Life in Patients With Standard External Compared to Custom-made Breast Prosthesis. | Biotech Hunter | Biotech Hunter