Clinical trial NCT06146231: Motiva Flora® Aesthetic Breast Recon® Clinical Study
Official title: Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mammaplasty
Breast Cancer
Poland Syndrome
Keywords: Reverse expansion
Aesthetic BreastRecon™
Hybrid breast reconstruction
Implant
Autologous tissue
Lead sponsor: Establishment Labs
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-11-24
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is designed as a pivotal, prospective, multicentric, interventional, open-label, single-arm, non-randomized and pre-market clinical investigation.
Primary purpose: OTHER

Brief summary: 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®.


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

Primary outcomes:
measure: Total adverse envent rate
timeFrame: 46 months
Secondary outcomes:
measure: Surgeon's overall satisfaction
timeFrame: 46 months
measure: Patient's anxiety and depression
timeFrame: 46 months
measure: Patient's satisfaction and quality of life impact
timeFrame: 46 months
measure: Device's performance: Device integrity
timeFrame: 6-16 months
measure: Changes in breast volume
timeFrame: 46 months
measure: Changes in breast vascularity
timeFrame: 46 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Bogotá
country: Colombia
facility: Hospital Universitario San Ignacio
city: San José
country: Costa Rica
facility: Hospital UNIBE
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: