Actively Recruiting
Motiva Flora Tissue Expander PMCF
Led by Establishment Labs · Updated on 2024-08-27
136
Participants Needed
5
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Motiva Flora Tissue Expander PMCF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given
- Genetically female, aged 18 years or older
- Need for tissue expansion as part of breast reconstruction after mastectomy
- Suitable clinical condition for breast implant after tissue expander placement
- Physical and cognitive ability to understand and follow surgeon's recommendations
- Completed radiotherapy at least 1 year before surgery
- Partial or total tumor volume decrease after radiotherapy
- Willingness and ability to comply with study requirements and follow-up visits
- Reasonable surgical risk
- History of non-metastatic breast cancer
- Willing to undergo MRI, CT scan, and other studies if required
- For substudy: willing to undergo one MRI and one CT during follow-up
You will not qualify if you...
- Pregnant, planning pregnancy within 1 year after surgery, or currently breastfeeding
- Implanted devices affected by magnetic fields (e.g., pacemakers, drug infusion devices)
- Abnormal blood test results after chemotherapy
- Tumor residues near tissue expansion area
- Inadequate tissue at expansion site due to radiotherapy effects or scarring
- Current or past infection in the expansion area
- Autoimmune diseases like lupus or scleroderma, or immunocompromised due to therapy
- Inadequate chest wall tissue from damage or surgery
- Participation in another drug or device research study
- Previous failure of tissue expansion or breast implant at intended site
- History of silicone sensitivity
- Employment or direct relation to staff or researchers of Establishment Labs or study sites
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Centro de Cirugía Plástica y Reconstructiva. Dra. Viviana Spröhnle Hospital Regional de Rancagua
Rancagua, Chile
Actively Recruiting
2
Centro Europeo de Cirugia
San José, Provincia de San José, Costa Rica
Actively Recruiting
3
The Panama Clinic Complejo Hospitalario Pacific Center
Panama City, Panama
Actively Recruiting
4
Centro de Patología de la Mama
Madrid, Spain
Actively Recruiting
5
Hospital Gregorio Marañón
Madrid, Spain
Actively Recruiting
Research Team
C
Catalina Solano
CONTACT
J
Jorge Villalobos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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