Breast AugmentationEMMIENCT03386682
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
A study testing ESTYME® MATRIX Breast Implants in people with Breast Augmentation and Breast Reconstruction, run by Symatese Aesthetics at 8 sites in France.
Trial summary
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction
- What is being tested?
- ESTYME® MATRIX Breast Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesFrance
- Study dates
- 23 Mar 2018to 12 Apr 2021
- 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
- Patient will be included if all of the following criteria are met:
- Subject of between 18 and 65 years old
- Candidate eligible for :
- unilateral or bilateral breast augmentation i. general breast enlargement: cosmetic purposes, providing symmetry to opposite breast in case of unilateral surgery ii. surgical correction of various congenital or acquired anomalies such as amastia, aplasia, hypomastia, hypoplasia, asymmetries, Poland's syndrome, ptosis …
- or immediate or delayed unilateral or bilateral breast reconstruction (for cancer, trauma, surgical loss of breast)
- Patient signs PIC (Patient Informed Consent) \& willing to comply with the protocol assessments and visits follow up
Who cannot join
- Patient will not be included if any of the following conditions exists:
- Local or systemic infection or abscess anywhere in the body
- Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
- Subject with previous tissue expansion
- Diagnosis of active cancer of any type for augmentation procedure subject
- Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
Show all 20Show fewer
- Subject who had nursed within three (3) months of implant surgery, or still breastfeeding
- Tissue characteristics determined clinically inadequate or unsuitable by the surgeon (i.e. tissue damage resulting from radiation, inadequate tissue or compromised vascularity, know complication wound healing)
- Previously implanted subject with a silicone implant or History of failure following cosmetic augmentation or subcutaneous mastectomy
- History of autoimmune disease such as but not limited to: lupus, scleroderma …
- Any condition or treatment for any condition which, in the opinion of the physician, may constitute an unwarranted surgical risk (e.g. anaesthesia allergy, high consumption smoking subject …)
- Anatomic or physiologic abnormality which could result to significant post-operative complications
- History of sensitivity of foreign materials or known allergy to any component of the ESTYME® MATRIX Silicone Gel-Filled Breast Implant
- Subject known for alcohol abuse/history
- Underlying disease (HIV positive Subject, HF (heart Failure), renal insufficiency, diabetes, hypertension, …)
- Subject with implanted metal or metal devices, history of claustrophobia, or other condition that would make a MRI scan prohibitive
- Unwilling to undergo any further surgery for revision
- Subject with willingness that are unrealistic/unreasonable with the risks involved with the surgical procedure
- Participating into any other clinical study or had participated into a clinical study without appropriate wash out period at the surgeon discretion
- Subject who has sociological, cultural or geographical factors which could interfere with evaluation or completion of the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre F.X. Michelet Chu Bordeaux
Bordeaux, 33076
Chu Pasteur
Nice, 06000
Clinique des Champs Elysées
Paris, 75008
Clinique BIZET
Paris, 75016
Institut du Sein
Paris, 75017
Hopital Tenon
Paris, 75020
Clinique Charcot
Sainte-Foy-lès-Lyon, 69500
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
Read the detailed description
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure
- Conditions
- Breast Augmentation, Breast Reconstruction
- Being tested
- ESTYME® MATRIX Breast Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTYME® MATRIX Breast ImplantsDevice
Breast implant surgery in breast reconstruction or breast augmentation
| Study group | Role | What they receive |
|---|---|---|
| ESTYME MATRIX | Experimental | Participants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s) Receives: Device: ESTYME® MATRIX Breast Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local complications
Evaluation of the safety 3 months post-implantation.
Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion.
Measured: 3 months
Satisfaction of the patient and the surgeon
Evaluation of the performance, 3 months post-implantation
Performance endpoint will be assessed by implant procedure success at 3 months defined as follows:
- satisfactory procedure duration for the surgeon
- satisfactory size of the incision for the surgeon
- implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants)
Measured: 3 months
Secondary outcomes (2)
Local complications
Evaluation of the safety, 1 year and two years post-implantation.
Safety endpoint: incidence of all Adverse Events (AE)/Serious Adverse Events (SAEs) @ 1 year and two years post procedure
Measured: 1 year and 2 years
Satisfaction of the patient and the surgeon
Performance endpoints are as follows:
- global surgeon satisfaction post-procedure assessed by the usability of the device during the procedure (current implant procedure): surgeon comfort level for the insertion/implantation of the prosthesis,
- global patient and surgeon satisfaction @ 1 year and 2 years post-procedure
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start23 Mar 2018
- Primary completion15 Apr 2019
- Study completion12 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symatese Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- EMMANUEL DELAY, MD, Principal investigator, Clinique Charcot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386682
- Sponsor's protocol ID
- Protocol CLIN PMI-002
- Acronym
- EMMIE
- Status last verified
- Apr 2021
- First submitted
- 18 Dec 2017
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. 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 and Anatomical Silicone Gel-Filled Breast Implants in the Breast Augmentation and Reconstruction - EMMIE Study
- ClinicalTrials.gov ID
- NCT03386682
- Acronym / sponsor ID
- EMMIE / Protocol CLIN PMI-002
- Conditions
- Breast Augmentation, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Symatese AestheticsIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 12 Apr 2021 (estimated)
- First posted
- 29 Dec 2017 (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 study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
Detailed description
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction at 3 months, 1 year and 2 years post-procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESTYME MATRIX | Experimental | Device: ESTYME® MATRIX Breast ImplantsParticipants who meet the requirements for breast augmentation or breast reconstruction surgeries and have been implanted with one or two ESTYME® MATRIX Breast Implant(s) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject of between 18 and 65 years old
- Candidate eligible for :
- Patient signs PIC (Patient Informed Consent) \& willing to comply with the protocol assessments and visits follow up
Key exclusion criteria (20 listed)
- Local or systemic infection or abscess anywhere in the body
- Existing carcinoma or pre-carcinoma of the breast without treatment or mastectomy treatment without appropriate wash out period for chemotherapy at the surgeon discretion
- Subject with previous tissue expansion
- Diagnosis of active cancer of any type for augmentation procedure subject
- Pregnant subject or intending to become pregnant within three (3) months of the implant procedure
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 Breast ImplantsBreast implant surgery in breast reconstruction or breast augmentation | Device | ESTYME MATRIX |
Primary outcome
Local complications
Time frame: 3 months
Evaluation of the safety 3 months post-implantation. Procedure-related adverse events/complications at 3 months post implant. Main foreseen complications: infection, haematoma, wound healing complication, fluid accumulation, early capsular contracture, rupture, extrusion.
Satisfaction of the patient and the surgeon
Time frame: 3 months
Evaluation of the performance, 3 months post-implantation Performance endpoint will be assessed by implant procedure success at 3 months defined as follows: * satisfactory procedure duration for the surgeon * satisfactory size of the incision for the surgeon * implant correct placement (absence of visible deformation of the gel, absence of rotation for anatomical implants)
2 secondary outcomes
Local complications
Time frame: 1 year and 2 years
Satisfaction of the patient and the surgeon
Time frame: 1 year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- 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.
EMMANUEL DELAY, MD principal investigator
Clinique Charcot
8 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 Breast Implants in people with Breast Augmentation and Breast Reconstruction, run by Symatese Aesthetics at 8 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 20 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Local complications (time frame: 3 months). The study lists 2 primary outcomes in all. 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 8 Apr 2021.