Motiva Flora® Aesthetic Breast Recon® Clinical Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEstablishment Labs
About this trial
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement of a permanent breast implant Ergonomix2®.
Eligibility criteria
Qualifiers
Genetically female, aged 18 years or older.
Subjects who had provided written informed consent form.
The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.
Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.
Disqualifiers
Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.
Abnormal hematological and biochemical values after chemotherapy.
High surgical risk according to the investigator.
Breast width larger than 18 cm
Trial design
Treatments tested in this trial
- Motiva Flora® Tissue Expander
Treatment groups
No treatment groups listed
Sponsors and collaborators
Establishment Labs
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov