Motiva Flora® Aesthetic Breast Recon® Clinical Study

NARecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 18, 2023

Primary Completion Date

April 30, 2024

Study Completion Date

April 30, 2027

Conditions
MammaplastyBreast CancerPoland Syndrome
Interventions
DEVICE

Motiva Flora® Tissue Expander

"This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant.~Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication.~To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study."

Trial Locations (4)

Unknown

RECRUITING

Universitair Ziekenhuis Gent, Ghent

NOT_YET_RECRUITING

Hospital Universitario San Ignacio, Bogotá

NOT_YET_RECRUITING

Hospital UNIBE, San José

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NAMSA

OTHER

lead

Establishment Labs

INDUSTRY

NCT06146231 - Motiva Flora® Aesthetic Breast Recon® Clinical Study | Biotech Hunter | Biotech Hunter