Motiva Flora® Aesthetic Breast Recon® Clinical Study

NCT06146231 | Recruiting

• 1 other identifier: CIP-001000
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 3

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®.

Conditions

Mammaplasty; Breast Cancer; Poland Syndrome

Keywords

Reverse expansion; Aesthetic BreastRecon™; Hybrid breast reconstruction; Implant; Autologous tissue

Outcome Measures

Primary Outcomes (1)

• Total adverse envent rate

  This variable will be assessed by the total incidence, seriousness, severity, causal relationship with the device, measure(s) taken for resolution, outcome, and duration of the various adverse events (AEs) reported during the surgery and follow-up period. The incidence of AEs, in terms of percentage, will be evaluated statistically with a 95% confidence interval. The analysis of the AEs will include: * All AEs reported during the time period in which Motiva Flora® TE remains implanted (up to a maximum of 16 months) * All AEs reported during the conduct of the whole clinical investigation (reconstruction process and 24 months follow-up)

  46 months

Secondary Outcomes (6)

• Surgeon's overall satisfaction

  46 months

• Patient's anxiety and depression

  46 months

• Patient's satisfaction and quality of life impact

  46 months

• Device's performance: Device integrity

  6-16 months

• Changes in breast volume

  46 months

Interventions

Motiva Flora® Tissue Expander DEVICE

This hybrid breast reconstruction involves a stage in which the tissue expander (Motiva Flora®) is used as intended for a conventional expansion. After achieving the desired volume, it is deflated in a controlled way to proceed with the execution of serial fat grafting procedures (reverse expansion). This also means the expander is implanted longer than indicated on its current Directions For Use. Once the reverse expansion is complete, the expander is replaced with a long-term breast implant. Motiva Implants Ergonomix2® Sterile Silicone Breast Implants will be used as per Standard of Care under the CE marked indication. To obtain the safest, most natural, and aesthetic outcomes, Ergonomix2® breast implants have been selected as the standard silicone breast implants for this study.

Also known as: Motiva Implants Ergonomix2® Sterile Silicone Breast Implants

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Establishment Labs: lead
• NAMSA: collaborator

Study Sites (4)

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

MeSH Terms

Conditions

Breast Neoplasms; Poland Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Syndactyly; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lilián Patricia Palma López

CONTACT

+34649713486; lpalma@establishmentlabs.com

Laura García Jimenez

CONTACT

lgarcia@establishmentlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a pivotal, prospective, multicentric, interventional, open-label, single-arm, non-randomized and pre-market clinical investigation.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 24, 2023
• Study Start: August 18, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); ES (1); CO (1)