Motiva Flora® Aesthetic Breast Recon® Clinical Study

Launched by ESTABLISHMENT LABS · Nov 21, 2023

Keywords

ClinConnect Summary

The Motiva Flora® Aesthetic Breast Recon® Clinical Study is looking at a new way to help women who need breast reconstruction after conditions like breast cancer or Poland Syndrome. This study uses a special process that starts with stretching the skin using a device called the Motiva Flora® Tissue Expander. After that, doctors will add fat from other parts of the body and finish by placing a permanent breast implant called Ergonomix2®. The goal is to improve the options available for women undergoing breast reconstruction.

To be eligible for this study, participants need to be women aged 18 and older who have had cancer treatments at least a year ago and need skin expansion for their breast reconstruction. They should have enough fat in areas like the abdomen or thighs for the procedure and must be able to follow the doctor’s instructions. Participants will be closely monitored throughout the process, including follow-up appointments, and may need to undergo an MRI scan for additional assessment. It’s important to note that certain health conditions or recent surgeries may prevent someone from joining the study.

Gender

FEMALE

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