Motiva Flora® Aesthetic Breast Recon® Clinical Study

Breast Cancer Clinical Trial

Official title:

Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146231
• Other study ID #: CIP-001000
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: Establishment Labs
• Contact: Lilián Patricia Palma López
• Phone: +34649713486
• Email: lpalma[@]establishmentlabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 2027
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Mammaplasty

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Ghent
Colombia	Hospital Universitario San Ignacio	Bogotá
Costa Rica	Hospital UNIBE	San José
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Establishment Labs	NAMSA

Countries where clinical trial is conducted

Belgium,  Colombia,  Costa Rica,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: All AEs reported during the time period in which Motiva Flora® TE remains implanted (up to a maximum of 16 months); All AEs reported during the conduct of the whole clinical investigation (reconstruction process and 24 months follow-up)	46 months
Secondary	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).	46 months
Secondary	Patient's anxiety and depression	Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale)	46 months
Secondary	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
Secondary	Device's performance: Device integrity	Percentage of Tissue Expander devices found without any damage at explantation.	6-16 months
Secondary	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
Secondary	Changes in breast vascularity	Percentage of cases where changes in vascularity of the filled zone were documented after the fat grafting process.	46 months