Bilateral Breast AugmentationEMMANCT05336526
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
A study testing ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in people with Bilateral Breast Augmentation, run by Symatese Aesthetics at 6 sites in France.
Trial summary
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Breast Augmentation
- What is being tested?
- ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 6 sitesFrance
- Study dates
- 18 Mar 2022to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years
- Eligible for bilateral breast augmentation in primary intention
- general breast enlargement for cosmetic purposes
- surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries*, Poland's syndrome*, ptosis … * correction of asymmetries and Poland's Syndrome with concomitant augmentation of the second breast (bilateral implantation)
- Signature of Patient Information Consent (PIC) \& willingness to comply with the protocol assessments and follow up visits
- Affiliation to the social security regime
Who cannot join
- Local or systemic infection or abscess anywhere in the body
- Existing carcinoma or pre-carcinoma of the breast with or without treatment
- History of subcutaneous mastectomy
- Subject with previous tissue expansion
- Diagnosis of active cancer of any type
- Pregnant subject or intending to become pregnant within three (3) months after the implant procedure (women of childbearing potential must use effective contraception from 1 month before the implantation procedure until 3 months after the implantation procedure)
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- Has breastfed within three (3) months the implant surgery, or is still breastfeeding
- Tissue characteristics determined as clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, known wound healing complications)
- Has been previously implanted with a silicone implant or history of failure following cosmetic augmentation
- History of autoimmune disease such as, but not limited to, lupus and scleroderma
- Any condition or treatment for any condition which, in the opinion of the investigator, may constitute an unwarranted surgical risk (e.g. severe lung or cardiac disease, unstable medical conditions, anaesthesia allergy, heavy smokers…)
- Anatomic or physiologic abnormality which could result to significant post-operative complications
- History of sensitivity to foreign materials or known allergy to any component of the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implant
- Known alcohol abuse or history of alcohol abuse
- Psychological instability
- Underlying disease (HIV-positive, heart failure, renal insufficiency, diabetes, hypertension)
- Implanted metal or metal devices, history of claustrophobia, or other condition that would make a magnetic resonance imaging (MRI) scan prohibitive
- Unwilling to undergo any further surgery for revision
- Unrealistic/unreasonable expectations that entail a risk for the surgical procedure
- Participating in another clinical study or within exclusion period of a previous clinical study as determined by the investigator
- Has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Urbain V Elsan
Avignon, 84000
Clinique Saint George
Nice, 06105
Clinique Sainte Geneviève
Paris, 75014
Clinique Bizet
Paris, 75016
Clinique du Rond Point des Champs Elysées
Paris, 75016
Clinique Charcot
Sainte-Foy-lès-Lyon, 69110
About this study
Official title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction.
An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).
- Conditions
- Bilateral Breast Augmentation
- Being tested
- ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast ImplantsDevice
Bilateral brest augmentation in primary intention
| Study group | Role | What they receive |
|---|---|---|
| ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants | Experimental | Participants who meet the requirements for bilateral breast augmentation in primary intention and have been implanted with ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants Receives: Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety : Incidence of implant and/or procedure-related adverse events/complications
Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant
Measured: 3 months post-procedure
Secondary outcomes (11)
Safety : Incidence of all AEs/SAEs
Safety endpoint will be assessed by the incidence of all AEs/SAEs at 1 year post-procedure
Measured: 1 year post-procedure
Safety : Incidence of all AEs/SAEs
Safety endpoint will be assessed by the incidence of all AEs/SAEs at 2 years post-procedure
Measured: 2 years post-procedure
Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration
Evaluation of surgeon 's satisfaction with procedure duration (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)
Measured: at the implant procedure
Performance, Implant procedure Success: Surgeon comfort evaluation with size incision
Evaluation of surgeon 's satisfaction with size of incision (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)
Measured: at the implant procedure
Performance, Implant procedure Success: Assessment of implant placement and deformation
Assessment of the implant correct placement (absence of visible deformation of the gel) at 3 months
Measured: 3 months post-procedure
Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis
Evaluation of surgeon's satisfaction with the usability of the device during the procedure (current implant procedure), the comfort level for insertion/implantation of the prothesis (5 options: Definitely satisfied, Satisfied, Somewhat satisfied, Somewhat dissatisfied, Definitely dissatisfied)
Measured: Discharge Visit, an average of 24h
Performance : number of steps of increase in bra cup size
Overall mean number of steps of increase in bra cup size at 3 months, 1 year and 2 years post-procedure
Measured: 3 months, 1 year and 2 years post-procedure
Performance : change in chest circumference at the level of the breasts
Overall mean change in chest circumference at the level of the breasts following the implant procedure analyzed as change in thoracic measure at 3 months, 1 years and 2 years post-procedure
Measured: 3 months, 1 year and 2 years post-procedure
Performance : satisfaction with the implant size choice
Suitability of the implant size choice at the time of the procedure analyzed as the difference between the final decision of the cup size for surgery and the cup size at 3 months, 1 year and 2 years
Measured: 3 months, 1 year and 2 years post-procedure
Performance : global satisfaction of the patient
Evaluation of global patient satisfaction at 3 months, 1 year and 2 years post-procedure with the BREAST EVALUATION QUESTIONNAIRE (BEQ55) (5 options: 1 = Very dissatisfied, 2 = Somewhat dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Somewhat satisfied, 5 = Very satisfied)
Measured: 3 months, 1 year and 2 years post-procedure
Performance : global satisfaction of the surgeon
Surgeon satisfaction at 3 months, 1 year and 2 years post-procedure evaluated as :
- degree of symmetry (4 options: NA, Good, Mediocre, Bad),
- degree of ptosis (3 options: Good, Mediocre, Bad),
- quality of contours (3 options: Good, Mediocre, Bad),
- implant placement (2 options: correct placement, visible deformation of the gel),
- global satisfaction (5 scoring options : definitely satisfied, satisfied, somewhat satisfied, somewhat dissatisfied and definitely dissatisfied).
Measured: 3 months, 1 year and 2 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start18 Mar 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Breast AugmentationStudies 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
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symatese Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336526
- Sponsor's protocol ID
- CLIN PMI-004
- Acronym
- EMMA
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)
- ClinicalTrials.gov ID
- NCT05336526
- Acronym / sponsor ID
- EMMA / CLIN PMI-004
- Conditions
- Bilateral Breast Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Symatese AestheticsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Apr 2022 (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 purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction.
An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants | Experimental | Device: ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast ImplantsParticipants who meet the requirements for bilateral breast augmentation in primary intention and have been implanted with ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years
- Eligible for bilateral breast augmentation in primary intention
- Signature of Patient Information Consent (PIC) \& willingness to comply with the protocol assessments and follow up visits
- Affiliation to the social security regime
Key exclusion criteria (21 listed)
- Local or systemic infection or abscess anywhere in the body
- Existing carcinoma or pre-carcinoma of the breast with or without treatment
- History of subcutaneous mastectomy
- Subject with previous tissue expansion
- Diagnosis of active cancer of any type
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 |
|---|---|---|
| ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast ImplantsBilateral brest augmentation in primary intention | Device | ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants |
Primary outcome
Safety : Incidence of implant and/or procedure-related adverse events/complications
Time frame: 3 months post-procedure
Safety endpoint will be assessed by the incidence of implant and/or procedure-related adverse events/complications at 3 months post implant
11 secondary outcomes
Safety : Incidence of all AEs/SAEs
Time frame: 1 year post-procedure
Safety : Incidence of all AEs/SAEs
Time frame: 2 years post-procedure
Performance, Implant procedure Success: Surgeon comfort evaluation with procedure duration
Time frame: at the implant procedure
Performance, Implant procedure Success: Surgeon comfort evaluation with size incision
Time frame: at the implant procedure
Performance, Implant procedure Success: Assessment of implant placement and deformation
Time frame: 3 months post-procedure
Performance :Surgeon comfort evaluation with comfort level for insertion/implantation of the prothesis
Time frame: Discharge Visit, an average of 24h
Performance : number of steps of increase in bra cup size
Time frame: 3 months, 1 year and 2 years post-procedure
Performance : change in chest circumference at the level of the breasts
Time frame: 3 months, 1 year and 2 years post-procedure
Performance : satisfaction with the implant size choice
Time frame: 3 months, 1 year and 2 years post-procedure
Performance : global satisfaction of the patient
Time frame: 3 months, 1 year and 2 years post-procedure
Performance : global satisfaction of the surgeon
Time frame: 3 months, 1 year and 2 years post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in people with Bilateral Breast Augmentation, run by Symatese Aesthetics at 6 sites in France.
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 6 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety : Incidence of implant and/or procedure-related adverse events/complications (time frame: 3 months post-procedure). 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 25 Jun 2024.