Hybrid breast reconstruction using Motiva Flora® Tissue Expander

Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study

This study is testing a new way to help people with breast cancer or Poland Syndrome get breast reconstruction using a special tissue expander and fat grafting to see if it looks and feels better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Establishment Labs (industry)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Ghent and 3 other locations)
• Trial ID: NCT06146231 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include genetically female individuals aged 18 and older who require tissue expansion for breast reconstruction and meet specific health criteria.

Not a fit: Patients who are currently pregnant or lactating, or those who have had recent pregnancies, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide patients with improved aesthetic outcomes and a more natural feel in breast reconstruction.

How similar studies have performed: While hybrid breast reconstruction techniques have been explored, this specific approach using the Motiva Flora® Tissue Expander is relatively novel.

Eligibility criteria

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 this trial is running

Ghent and 3 other locations

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

Study contacts

• Study coordinator: Lilián Patricia Palma López

Conditions: Mammaplasty, Breast Cancer, Poland Syndrome, Reverse expansion, Aesthetic BreastRecon™, Hybrid breast reconstruction, Implant, Autologous tissue