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Recruiting NCT06146231

Motiva Flora® Aesthetic Breast Recon® Clinical Study

No phase Interventional Mammaplasty Breast Cancer Poland Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motiva Flora® Tissue Expander.
Who it may be relevant to
Registry conditions: Mammaplasty, Breast Cancer, Poland Syndrome. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Colombia, Costa Rica, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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®.

Interventions

  • Device Motiva Flora® Tissue Expander
    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.

Primary outcome measures

  • Total adverse envent rate [Time frame: 46 months]
Secondary outcome measures (6)
  • Surgeon's overall satisfaction [Time frame: 46 months]
  • Patient's anxiety and depression [Time frame: 46 months]
  • Patient's satisfaction and quality of life impact [Time frame: 46 months]
  • Device's performance: Device integrity [Time frame: 6-16 months]
  • Changes in breast volume [Time frame: 46 months]
  • Changes in breast vascularity [Time frame: 46 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
  • Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
  • Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
  • Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Belgium · 1 center
  • Universitair Ziekenhuis Gent — Ghent
Colombia · 1 center
  • Hospital Universitario San Ignacio — Bogotá
Costa Rica · 1 center
  • Hospital UNIBE — San José
Spain · 1 center
  • Hospital de la Santa Creu i Sant Pau — Barcelona

Identifiers

NCT: NCT06146231 · CIP-001000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗