Breast Implant RuptureELEGANTNCT05987475
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
An observational study of Breast Implant Rupture and Breast Implant; Complications, run by Euromi Biosciences at 1 site in France.
Trial summary
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implant Rupture, Breast Implant; Complications
- What is being tested?
- Breast reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2023to Sep 2034
- Phase
- Observational
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Two groups of participants will be distinguished: * Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic reasons) * Group 2: Insertion of an implant in the event of a breast reconstruction (eg.. following breast cancer)
Who may be able to join
- Female;
- 18 years old and above, and under 60 years old;
- has approved and signed the informed consent form;
- eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
- Willing to be followed up for a period of 10 years.
Who cannot join
- Informed pregnancy or breastfeeding at the time of inclusion
- Known hypersensitivity and / or allergy to silicone;
- Not understanding or not accepting the risks of further surgeries during follow-up;
- Body mass index > 40 kg/m²;
- Diabetes
- HbA1c levels > 7,5%;
Show all 23Show fewer
- History of repeated failure with the implantation of similar implants;
- Tissue or fat insufficiency;
- Progressive breast cancer large tumours (>5 cm), late cancer stage and deep tumours;
- Grossly positive axillary involvement / or chest wall involvement;
- High risk of cancer recurrence;
- Tissue damage in the implant area due to irradiation of the thoracic wall;
- Pre-existing pathology in the implant area;
- General infection or infection in the implant area;
- Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;
- History or presence of an autoimmune disease;
- Immunocompromised;
- History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids;
- Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;
- Concomitantly part of another interventional clinical trial.
- Under supervision or legal guardianship
- Deprived of liberty by a judicial or administrative decision
- Not affiliated to health insurance system or is a beneficiary of such coverage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Nancy
CHRU Nancy, +33 3 83 85 85 85, communication@chru-nancy.fr
About this study
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
- Being tested
- Breast reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reconstructionProcedure or surgery
Also called Breast augmentation
Breast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of capsular contracture
To describe the rate of capsular contracture. Capsular contracture will be evaluated according to the Baker classification (from I to IV with grade III/IV considered as retractile capsular contractures).
Measured: From implantation to end of study (10-year)
Post-surgery rupture
To describe the rate of post-surgery rupture. Rupture will be evaluated based on cases of hardening or deflation, based on clinical signs and if deemed necessary by the investigator, by medical imaging (mammography, ultrasound, MRI).
Measured: From implantation to end of study (10-year)
Secondary outcomes (5)
Participant's QoL
Quality of life: will be evaluated using the French version of the Breast Body Image Scale (BBIS).
Measured: From implantation to end of study (10-year)
Breast implant survival rate.
Breast implant survival rate: the event will be defined as the removal of a breast implant for any reason other than participant's wish. Breast survival will be defined as the absence of breast implant removal. The analysis will be at the implant level and at the participant level, overall and by group.
Measured: From implantation to end of study (10-year)
Frequency of occurrence of other adverse events and complications
Evaluate the frequency of occurrence of other adverse events and complications recorded during the study
Measured: From implantation to end of study (10-year)
Participant's and investigator's satisfaction regarding the aesthetic result
Participant and investigator satisfaction with aesthetic results: questionnaire using generic 6-level Likert scale: extremely dissatisfied, very dissatisfied, somewhat dissatisfied, somewhat satisfied, very satisfied, extremely satisfied.
Measured: From implantation to end of study (10-year)
Reoperation rate
Reoperation will be defined as a new operation at the breast implant site for any cause.
The analyses will be performed at the implant level and at the participant level, overall and by group
Measured: From implantation to end of study (10-year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Oct 2023
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant RuptureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Euromi Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987475
- Sponsor's protocol ID
- ID RCB: 2023-A00101-44
- Acronym
- ELEGANT
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
- ClinicalTrials.gov ID
- NCT05987475
- Acronym / sponsor ID
- ELEGANT / ID RCB: 2023-A00101-44
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Euromi BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (estimated)
- First posted
- 14 Aug 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.
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups of participants will be distinguished: * Group 1: Insertion of an implant in the event of a breast augmentation (for aesthetic reasons) * Group 2: Insertion of an implant in the event of a breast reconstruction (eg.. following breast cancer)
Key inclusion criteria (5 listed)
- Female;
- 18 years old and above, and under 60 years old;
- has approved and signed the informed consent form;
- eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
- Willing to be followed up for a period of 10 years.
Key exclusion criteria (23 listed)
- Informed pregnancy or breastfeeding at the time of inclusion
- Known hypersensitivity and / or allergy to silicone;
- Not understanding or not accepting the risks of further surgeries during follow-up;
- Body mass index > 40 kg/m²;
- Diabetes
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 |
|---|---|---|
| Breast reconstructionAlso: Breast augmentationBreast reconstruction and breast augmentation based on the indications as listed out in the instructions for use of the medical device under investigation | Procedure or surgery | – |
Primary outcome
Rate of capsular contracture
Time frame: From implantation to end of study (10-year)
To describe the rate of capsular contracture. Capsular contracture will be evaluated according to the Baker classification (from I to IV with grade III/IV considered as retractile capsular contractures).
Post-surgery rupture
Time frame: From implantation to end of study (10-year)
To describe the rate of post-surgery rupture. Rupture will be evaluated based on cases of hardening or deflation, based on clinical signs and if deemed necessary by the investigator, by medical imaging (mammography, ultrasound, MRI).
5 secondary outcomes
Participant's QoL
Time frame: From implantation to end of study (10-year)
Breast implant survival rate.
Time frame: From implantation to end of study (10-year)
Frequency of occurrence of other adverse events and complications
Time frame: From implantation to end of study (10-year)
Participant's and investigator's satisfaction regarding the aesthetic result
Time frame: From implantation to end of study (10-year)
Reoperation rate
Time frame: From implantation to end of study (10-year)
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 29 Nov 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Rupture and Breast Implant; Complications, run by Euromi Biosciences at 1 site 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 5 inclusion and 23 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of capsular contracture (time frame: From implantation to end of study (10-year)). 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 29 Nov 2023.