Motiva Flora® Aesthetic Breast Recon® Clinical Study (NCT06146231) | Clinical Trial Compass
RecruitingNot Applicable
Motiva Flora® Aesthetic Breast Recon® Clinical Study
Belgium, Colombia, Costa Rica66 participantsStarted 2023-08-18
Plain-language 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®.
Who can participate
Age range18 Years
SexFEMALE
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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.
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.
✕. 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.