Hybrid breast reconstruction using Motiva Flora® Tissue Expander

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on a hybrid approach to breast reconstruction for patients requiring tissue expansion, particularly those affected by conditions like breast cancer and Poland Syndrome. The process begins with the use of the Motiva Flora® Tissue Expander to prepare the breast area, followed by a series of fat grafting sessions, and concludes with the placement of a permanent Ergonomix2® breast implant. The study aims to evaluate the effectiveness and aesthetic outcomes of this innovative reconstruction method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Genetically female, aged 18 years or older.
2. Subjects who had provided written informed consent form.
3. The participant needs tissue expansion as part of breast reconstruction treatment, which may include immediate reconstruction.
4. Clinical condition to allow reverse expansion breast reconstruction, at the investigator's discretion.
5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeon criteria.
6. Complete radiotherapy and chemotherapy at least one year before surgery.
7. BMI between 18.5 and 30.0 (average classified weight).
8. Physical and cognitive capacity to understand and follow the surgeon's recommendations.
9. To be able and willing to comply with all study requirements, including attending follow-up appointments.

   Only Sub study participants
10. Provide additional consent to undergo an MRI with contrast.

Exclusion Criteria:

1. Current pregnancy or lactation, or full-term pregnancy or lactation at any point during the clinical investigation.
2. Abnormal hematological and biochemical values after chemotherapy.
3. High surgical risk according to the investigator.
4. Breast width larger than 18 cm
5. Tumor residues in or near the area where tissue expansion is performed.
6. Subjects with metastatic breast cancer
7. Significant Breast ptosis or poor skin quality
8. 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.
9. Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
10. Current or previous infection in the area where the expansion occurs.
11. Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
13. History of silicone sensitivity.
14. Active smokers
15. Previous attempts of breast reconstruction
16. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
17. Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
18. Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
19. 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's running

• Universitair Ziekenhuis Gent
  Ghent, Belgium Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Spain Recruiting
• Hospital Universitario San Ignacio
  Bogotá, Colombia Not yet recruiting
• Hospital UNIBE
  San José, Costa Rica Not yet recruiting

Study contacts

• Study coordinator: Lilián Patricia Palma López
• Email: lpalma@establishmentlabs.com
• Phone: +34649713486

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.