MammaplastyNCT06146231
Motiva Flora® Aesthetic Breast Recon® Clinical Study
A study testing Motiva Flora® Tissue Expander in people with Mammaplasty and Breast Cancer, run by Establishment Labs at 4 sites in 4 countries.
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®. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammaplasty, Breast Cancer, Poland Syndrome
- What is being tested?
- Motiva Flora® Tissue Expander
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 18 Aug 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- Inadequate chest wall tissue due to damage caused by radiotherapy, tight skin grafts, or radical resection of the pectoralis major muscle.
- Current or previous infection in the area where the expansion occurs.
- Any condition that impedes magnetic resonance imaging (MRI), including implanted metal device, claustrophobia, or other ailments that would prohibit MRI scan.
- Presence of autoimmune diseases such as lupus or scleroderma, or immunocompromised participants due to immunosuppressive or steroid therapy.
- History of silicone sensitivity.
- Active smokers
- Previous attempts of breast reconstruction
- Subjects who, in the opinion of the investigator, are considered part of any vulnerable population
- Subjects with affiliation to the Sponsor, sites or investigators, including relatives.
- Participants who do not live in the procedure's country make it impossible to assist in follow-up visits.
- Subjects who are participating in other investigation(s) which may affect the outcomes or ability to comply follow-up requirements of this study
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Laura García Jimenez contact
4 sites in 4 countries
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Gent
Ghent
Filip Stillaert, PhD. MD., stillaert@me.com
Jessie De Kinder, Jessie.DeKinder@uzgent.be
Colombia1 site, 1 recruiting
- Not yet recruiting
Hospital Universitario San Ignacio
Bogotá
Juan Carlos Zambrano-Bürgl, MD, jc.zambrano.b@gmail.com
Juan Carlos Zambrano-Bürgl, MD
Costa Rica1 site, 1 recruiting
- Not yet recruiting
Hospital UNIBE
San José
Diego Solís Barrantes, dsolis@unibe.ac.cr
Francisco Vargas Villalobos, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Silvia Condrea, SCondrea@santpau.cat
Jaume Masià Ayala, MD
About this study
Official title: Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
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®.
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Being tested
- Motiva Flora® Tissue Expander
- Keywords
- Reverse expansion, Aesthetic BreastRecon™, Hybrid breast reconstruction, Implant, Autologous tissue
- Medical subject headings
- Breast Neoplasms, Poland Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motiva Flora® Tissue ExpanderDevice
Also called Motiva Implants Ergonomix2® Sterile Silicone Breast Implants
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 46 months
Secondary outcomes (6)
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).
Measured: 46 months
Patient's anxiety and depression
Patient's anxiety and depression using the HADS (The Hospital Anxiety Depression Scale)
Measured: 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.
Measured: 46 months
Device's performance: Device integrity
Percentage of Tissue Expander devices found without any damage at explantation.
Measured: 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.
Measured: 46 months
Changes in breast vascularity
Percentage of cases where changes in vascularity of the filled zone were documented after the fat grafting process.
Measured: 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start18 Aug 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as a pivotal, prospective, multicentric, interventional, open-label, single-arm, non-randomized and pre-market clinical investigation.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Establishment Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146231
- Sponsor's protocol ID
- CIP-001000
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motiva Flora® Tissue Expander as a Support for the Creation of an Autologous Adipose Matrix for Hybrid Breast Reconstruction: a Pivotal Study
- ClinicalTrials.gov ID
- NCT06146231
- Acronym / sponsor ID
- CIP-001000
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Keywords
- Reverse expansion, Aesthetic BreastRecon™, Hybrid breast reconstruction, Implant, Autologous tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Establishment LabsIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This study is designed as a pivotal, prospective, multicentric, interventional, open-label, single-arm, non-randomized and pre-market clinical investigation.
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motiva Flora® Tissue ExpanderAlso: Motiva Implants Ergonomix2® Sterile Silicone Breast ImplantsThis 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. | Device | – |
Primary outcome
Total adverse envent rate
Time frame: 46 months
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)
6 secondary outcomes
Surgeon's overall satisfaction
Time frame: 46 months
Patient's anxiety and depression
Time frame: 46 months
Patient's satisfaction and quality of life impact
Time frame: 46 months
Device's performance: Device integrity
Time frame: 6-16 months
Changes in breast volume
Time frame: 46 months
Changes in breast vascularity
Time frame: 46 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura García Jimenez contact
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motiva Flora® Tissue Expander in people with Mammaplasty and Breast Cancer, run by Establishment Labs at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Colombia, Costa Rica, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lilián Patricia Palma López (+34649713486, lpalma@establishmentlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total adverse envent rate (time frame: 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.