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| Name | Class |
|---|---|
| NAMSA | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motiva Flora® Tissue Expander | Device | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total adverse envent rate | This variable will be assessed by the total incidence, seriousness, severity, causal relationship with the device, measure(s) taken for resolution, outcome, and duration of the various adverse events (AEs) reported during the surgery and follow-up period. The incidence of AEs, in terms of percentage, will be evaluated statistically with a 95% confidence interval. The analysis of the AEs will include:
| 46 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon's overall satisfaction | Surgeon's overall satisfaction with reconstruction process and results according to the Global Aesthetic Improvement Scale (GAIS), a 5-point Likert scale: 1) Worse (The appearance is worse than the original condition); 2) No change (The appearance is essentially the same as the original condition); 3) Improved (Obvious improvement in appearance from the initial condition, but a touch-up or retreatment is indicated); 4) Much improved (Marked improvement in appearance from the initial condition, but not completely optimal for this patient. A touch-up would slightly improve the result) and 5) Very much improved (Optimal cosmetic result for the implant in this patient). |
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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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilián Patricia Palma López | Contact | +34649713486 | lpalma@establishmentlabs.com | |
| Laura García Jimenez | Contact | lgarcia@establishmentlabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent | Recruiting | Ghent | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011045 | Poland Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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This study is designed as a pivotal, prospective, multicentric, interventional, open-label, single-arm, non-randomized and pre-market clinical investigation.
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| 46 months |
| Patient's anxiety and depression | Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale) | 46 months |
| Patient's satisfaction and quality of life impact | Quality of life and satisfaction levels will be assessed using validated international tool Breast-Q. | 46 months |
| Device's performance: Device integrity | Percentage of Tissue Expander devices found without any damage at explantation. | 6-16 months |
| Changes in breast volume | Percentage of cases where enlargement of the initial breast volume was achieved after the fat grafting process and changes in vascularity of the filled zone documented. after the fat grafting process. | 46 months |
| Changes in breast vascularity | Percentage of cases where changes in vascularity of the filled zone were documented after the fat grafting process. | 46 months |
| Hospital Universitario San Ignacio | Not yet recruiting | Bogotá | Colombia |
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| Hospital UNIBE | Not yet recruiting | San José | Costa Rica |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D013576 | Syndactyly |
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |