Motiva Flora® Aesthetic Breast Recon® Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2027-04-30

Brief Summary

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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®.

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Detailed Description

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Conditions

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Mammaplasty Breast Cancer Poland Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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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.

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.

Intervention Type DEVICE

Other Intervention Names

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Motiva Implants Ergonomix2® Sterile Silicone Breast Implants

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No