Trial Title:
Motiva Flora® Aesthetic Breast Recon® Clinical Study
NCT ID:
NCT06146231
Condition:
Mammaplasty
Breast Cancer
Poland Syndrome
Conditions: Official terms:
Poland Syndrome
Conditions: Keywords:
Reverse expansion
Aesthetic BreastRecon™
Hybrid breast reconstruction
Implant
Autologous tissue
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This study is designed as a pivotal, prospective, multicentric, interventional,
open-label, single-arm, non-randomized and pre-market clinical investigation.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Motiva Flora® Tissue Expander
Description:
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.
Other name:
Motiva Implants Ergonomix2® Sterile Silicone Breast Implants
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®.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitair Ziekenhuis Gent
Address:
City:
Ghent
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Filip Stillaert, PhD. MD.
Email:
stillaert@me.com
Contact backup:
Last name:
Jessie De Kinder
Email:
Jessie.DeKinder@uzgent.be
Investigator:
Last name:
Filip Stillaert, PhD. MD.
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario San Ignacio
Address:
City:
Bogotá
Country:
Colombia
Status:
Not yet recruiting
Contact:
Last name:
Juan Carlos Zambrano-Bürgl, MD
Email:
jc.zambrano.b@gmail.com
Investigator:
Last name:
Juan Carlos Zambrano-Bürgl, MD
Email:
Principal Investigator
Facility:
Name:
Hospital UNIBE
Address:
City:
San José
Country:
Costa Rica
Status:
Not yet recruiting
Contact:
Last name:
Diego Solís Barrantes
Email:
dsolis@unibe.ac.cr
Investigator:
Last name:
Francisco Vargas Villalobos, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alfredo Vargas Villalobos, MD
Email:
Sub-Investigator
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Silvia Condrea
Email:
SCondrea@santpau.cat
Investigator:
Last name:
Jaume Masià Ayala, MD
Email:
Principal Investigator
Investigator:
Last name:
Silvia Condrea, MD
Email:
Sub-Investigator
Start date:
August 18, 2023
Completion date:
April 2027
Lead sponsor:
Agency:
Establishment Labs
Agency class:
Industry
Collaborator:
Agency:
NAMSA
Agency class:
Other
Source:
Establishment Labs
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146231
