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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.