Actively Recruiting
Motiva Flora® Aesthetic Breast Recon® Clinical Study
Led by Establishment Labs · Updated on 2025-11-26
66
Participants Needed
4
Research Sites
188 weeks
Total Duration
On this page
Sponsors
E
Establishment Labs
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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®.
CONDITIONS
Official Title
Motiva Flora® Aesthetic Breast Recon® Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Genetically female, aged 18 years or older
- Provided written informed consent
- Need tissue expansion for breast reconstruction, including immediate reconstruction
- Clinical condition allows reverse expansion breast reconstruction
- Sufficient fat in donor sites (abdomen, gluteus, hips, thighs) per surgeon
- Completed radiotherapy and chemotherapy at least one year before surgery
- Body mass index between 18.5 and 30.0
- Physical and cognitive ability to understand and follow surgeon's recommendations
- Able and willing to comply with all study requirements including follow-up visits
- For sub-study participants: additional consent to undergo MRI with contrast
You will not qualify if you...
- Current pregnancy or lactation, or during the study
- Abnormal hematological and biochemical values after chemotherapy
- High surgical risk as judged by investigator
- Breast width larger than 18 cm
- Tumor residues near tissue expansion area
- Metastatic breast cancer
- Significant breast ptosis or poor skin quality
- Inadequate tissue at expansion site due to prior treatments or scars
- Inadequate chest wall tissue from damage or surgery
- Current or previous infection where expansion occurs
- Conditions preventing MRI such as implanted metal device or claustrophobia
- Autoimmune diseases or immunocompromised status due to therapy
- History of silicone sensitivity
- Active smokers
- Previous breast reconstruction attempts
- Considered vulnerable population by investigator
- Affiliation with Sponsor, sites, investigators, or relatives
- Living outside procedure country preventing follow-up
- Participation in other studies affecting outcomes or follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Universitair Ziekenhuis Gent
Ghent, Belgium
Actively Recruiting
2
Hospital Universitario San Ignacio
Bogotá, Colombia
Not Yet Recruiting
3
Hospital UNIBE
San José, Costa Rica
Not Yet Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
Research Team
L
Lilián Patricia Palma López
CONTACT
L
Laura García Jimenez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
0
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