Motiva Flora® Aesthetic Breast Recon® Clinical Study

Last updated: November 29, 2023
Sponsor: Establishment Labs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Breast Cancer

Cancer

Treatment

Motiva Flora® Tissue Expander

Clinical Study ID

NCT06146231
CIP-001000
  • Ages > 18
  • Female

Study 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

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 theinvestigator's discretion.
  5. Sufficient fat in donor sites (abdomen, gluteus, hips, and thighs) per plastic surgeoncriteria.
  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'srecommendations.
  9. To be able and willing to comply with all study requirements, including attendingfollow-up appointments. Only Sub study participants
  10. Provide additional consent to undergo an MRI with contrast.

Exclusion

Exclusion Criteria:

  1. Current pregnancy or lactation, or full-term pregnancy or lactation at any pointduring 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, atthe surgeon's discretion, due to previous radiotherapy, ulceration, vascularinvolvement, 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 metaldevice, claustrophobia, or other ailments that would prohibit MRI scan.
  12. Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromisedparticipants 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 anyvulnerable 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 assistin follow-up visits.
  19. Subjects who are participating in other investigation(s) which may affect the outcomesor ability to comply follow-up requirements of this study

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Motiva Flora® Tissue Expander
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Universitair Ziekenhuis Gent

    Ghent,
    Belgium

    Active - Recruiting

  • Hospital Universitario San Ignacio

    Bogotá,
    Colombia

    Site Not Available

  • Hospital UNIBE

    San José,
    Costa Rica

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

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