The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of Motiva Flora® TE in breast reconstruction surgery. The study will include 136 women, planned for staged breast reconstruction, in 6 countries (Spain, Belgium, France, Costa Rica, Chile and Panama). Breast tissue expansion and the final breast implant will be performed using devices from the Motiva Flora® TE catalogue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
136
tissue expander based breast reconstruction
Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
Rancagua, Chile
RECRUITINGCentro Europeo de Cirugia
San José, Provincia de San José, Costa Rica
RECRUITINGThe Panama Clinic Complejo Hospitalario Pacific Center
Panama City, Panama
Incidence of the device and procedure-related adverse events
Cumulative incidence of the device and procedure-related adverse events as assessed by occurrence, seriousness, severity, causal relationship with the device
Time frame: 6 months follow-up
Perceived success of breast tissue expansion
Success of the process as perceived by the investigator considering change in final breast volume and comparison with expected volume
Time frame: 6 months follow-up
Expected completion of breast tissue expansion
Evaluate the time it took to reach the desired expansion following planning.
Time frame: Up to 6 months follow-up
Satisfaction assessed by the 5 point Likert scale
\- Surgeon's overall satisfaction (1=very significant improvement, 2=significant improvement, 3=improvement, 4=no change and 5=decline) at each follow-up visit.
Time frame: 6 months follow-up
Integrity of the fixing tabs defined as tabs being intact at explantation
Observation of Integrity of the fixing tabs defined as tabs being intact at explanation with no detachments and cuts.
Time frame: During the intervention/procedure/surgery for explantation
MRI and potential incidents
Incidents attributable to MR exposure.
Time frame: Up to 6 months follow-up
MRI and port locator performance measured through accurate locator function
Motiva Flora® Port locator performance after MRI measured through accurate location defined when the green light on the device comes on
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centro de Patología de la Mama
Madrid, Spain
RECRUITINGHospital Gregorio Marañón
Madrid, Spain
RECRUITINGTime frame: Up to 6 months follow-up
Device interference on MRI
Device interference on MRI measured through artifact size
Time frame: Up to 6 months follow-up
In vivo testing of device interference with CT radiotherapy planning.
Radiological Report after undergo CT: \- Interference with CT.
Time frame: Up to 6 months follow-up