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New treatment option for Mammaplasty
Official title Motiva Flora® Aesthetic Breast Recon® Clinical Study
ClinicalTrials.gov ID: NCT06146231
What this study is testing
- What it's testing
- 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®.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Genetically female, aged 18 years or older.
- people 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.
- Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
You likely can't join if
- 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
- Tumor residues in or near the area where tissue expansion is performed.
- people with metastatic breast cancer
See the full eligibility criteria
- Genetically female, aged 18 years or older.
- people 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.
- Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
- Complete radiotherapy and chemotherapy at least one year before surgery.
- BMI between 18.5 and 30.0 (average classified weight).
- Physical and cognitive capacity to understand and follow the surgeon's recommendations.
- To be able and willing to comply with all study requirements, including attending follow-up appointments. Only Sub study participants
- Provide additional consent to undergo an MRI with contrast.
- 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
- Tumor residues in or near the area where tissue expansion is performed.
- people with metastatic breast cancer
- Significant Breast ptosis or poor skin quality
- Participants who do not have adequate tissue at the intended site for expansion, at the surgeon's discretion, due to previous radiotherapy, ulceration, vascular involvement, history of impaired wound healing, or...
- Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
- Current or previous infection in the area where the expansion occurs.
- Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
- Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
- History of silicone sensitivity.
- Active smokers
- Previous attempts of breast reconstruction
- people who, in the opinion of the investigator, are considered part of any vulnerable population
- people with affiliation to the Sponsor, sites or investigators, including relatives.
- Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
- people who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
- Bogotá, Colombia
- San José, Costa Rica
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium; Bogotá, Colombia; San José, Costa Rica; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.