Motiva Flora® Aesthetic Breast Recon® Clinical Study

Recruiting now · Not applicable

Conditions studied: Mammaplasty, Breast Cancer, Poland Syndrome

In brief

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®.

Key facts

Study ID

NCT06146231

Run by

Establishment Labs

People needed

66

Starts

2023-08-18

Expected to finish

2027-04-01

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify 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.
• Subjects 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 mastectomy scar deformity.
• 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
• Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
• Subjects 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.
• Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study

Where it is running

• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitario San Ignacio — Bogotá, Colombia
• Hospital UNIBE — San José, Costa Rica

Full record on ClinicalTrials.gov

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