Breast AugmentationNCT07679594
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
An observational study of Breast Augmentation and Breast Reconstruction, run by GCA (Eurosilicone) at 2 sites in 2 countries.
Trial summary
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation
- What is being tested?
- Breast augmentation surgery and Breast reconstruction surgery
- Type of treatment
- Surgery or procedure
- How many people
- 650 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Mar 2026to 31 Dec 2038
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from centers participating to the study.
Who may be able to join
- The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.
- Genetic female subjects aged between 18 and 65 years old.
- Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
- Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs (synthetic or natural).
- Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.
Who cannot join
- Subjects with a BMI >35.
- Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
- Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.
- Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
- Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.
- Subjects with known previous history of a sensitivity to silicone who, in the opinion of the Investigator, are unsuitable for surgery.
Show all 12Show fewer
- Subjects with an active infection who are unsuitable for surgery unless, in the opinion of the investigator, they are treated and cleared by the investigator.
- Subjects with a history of abscesses anywhere in the body who, in the opinion of the Investigator, are unsuitable for surgery.
- Subjects with a known history of compromised wound healing.
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Women who are pregnant and/or current breast feeders who do not stop breast feeding within 3 months of getting breast implants.
- Patients who have local recurrence or metastatic carcinoma at the time of insertion of breast implant.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
France1 site, 1 recruiting
- Recruiting
Dr Guillaume Lasserre
Villefranche-sur-Saône
Dr Guillaume Lasserre, dr.lasserre.guillaume@orange.fr
Guillaume Lasserre
Spain1 site, 1 recruiting
- Recruiting
DScultp Clinic
Barcelona
Dr David Sanz, administracion@plasticabarcelona.com
David Sanz
About this study
Official title: A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction, Revision Breast Reconstruction, Breast Augmentation and Breast Reconstruction
- Being tested
- Breast augmentation surgery, Breast reconstruction surgery
- Keywords
- Luna XT, Anatomical breast implant, Mammary implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast augmentation surgeryProcedure or surgery
Also called Cosmetic breast implant surgery, Aesthetic breast implant surgery
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
Breast reconstruction surgeryProcedure or surgery
Also called Immediate breast reconstruction, Delayed breast reconstruction
The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.
| Study group | Role | What they receive |
|---|---|---|
| Aesthetic indications | Primary or revision breast augmentation with or without mastopexy. Receives: Procedure: Breast augmentation surgery | |
| Medical indications | Primary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy. Receives: Procedure: Breast reconstruction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and rate of implant rupture
Measured: 10 years
Frequency and rate of capsular contracture Baker III-IV
Measured: 10 years
Secondary outcomes (3)
Rate of the secondary surgical procedures required for correction of complications
Measured: 10 years
Rate and frequency of local complications
These complications may be related to the device itself or to the surgical procedure:
- Capsular contracture of Baker Grade I-II
- Haematoma
- Rupture
- Seroma
- Severe and continuing pain
- Post-operative infection
- Explantation as a result of infection
- Implant displacement/extrusion
- Implant misplacement/malrotation
- Wrinkling/folds
- Breast Implant Associate Anaplastic Large Cell Lymphoma
- Breast Implant Ilness (BII)/ Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (Asia)
- Delayed or abnormal wound healing occurring within the first 3 months of surgery
- Any other complications considered by the Investigator to be related to the device or surgical procedure
Measured: 10 years
Patient satisfaction
This will be determined using a questionnaire assessing the qualify of life.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start30 Mar 2026
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2038 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCA (Eurosilicone)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679594
- Sponsor's protocol ID
- CLA-0007
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Observational, Non-comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Eurosilicone LunaXT Range of Silicone Breast Implants When Used in Breast Implantation.
- ClinicalTrials.gov ID
- NCT07679594
- Acronym / sponsor ID
- CLA-0007
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction, Revision Breast Reconstruction, Breast Augmentation and Breast Reconstruction
- Keywords
- Luna XT, Anatomical breast implant, Mammary implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- GCA (Eurosilicone)Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 1 Jul 2026 (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 goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical implantation in female population between 18 and 65 years old undergoing primary or revision of breast augmentation or breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aesthetic indications | – | Procedure: Breast augmentation surgeryPrimary or revision breast augmentation with or without mastopexy. |
| Medical indications | – | Procedure: Breast reconstruction surgeryPrimary or revision of breast reconstruction. Immediate or delayed reconstruction. With or without associated chemotherapy and/or radiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from centers participating to the study.
Key inclusion criteria (5 listed)
- The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended.
- Genetic female subjects aged between 18 and 65 years old.
- Subjects who underwent single or bilateral breast implantation with the study device for one of the following reasons:
- Primary breast reconstruction following mastectomy (both for one-stage or two-stage surgeries, including patients with previous radiotherapy and who have ADMs (synthetic or natural).
- Primary breast augmentation (cosmetic surgery) with or without mastopexy iii. Breast revision surgery with or without mastopexy c) Subjects who have received a Eurosilicone Luna implant. d) Subjects who have provided informed consent and can adhere to the requirements of follow-up appointments as per the study protocol.
Key exclusion criteria (12 listed)
- Subjects with a BMI >35.
- Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere with wound healing and blood clotting, a weakened immune system, reduced blood supply to the breast tissue or any other condition for which breast implants are contraindicated.
- Subjects who have participated in a clinical study which involve chemical or drug study within 3 months prior to surgery, with the exception of subjects who are participating in breast cancer-related clinical studies.
- Subjects with insufficient tissue covering due to either radiation damage on the chest wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.
- Subjects who, in the Investigator's clinical opinion, have existing local or metastatic carcinoma of the breast that is unlikely to be fully excised at the time of insertion of the breast implant.
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 augmentation surgeryAlso: Cosmetic breast implant surgery, Aesthetic breast implant surgeryThe procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications. | Procedure or surgery | Aesthetic indications |
| Breast reconstruction surgeryAlso: Immediate breast reconstruction, Delayed breast reconstructionThe procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications. | Procedure or surgery | Medical indications |
Primary outcome
Frequency and rate of implant rupture
Time frame: 10 years
Frequency and rate of capsular contracture Baker III-IV
Time frame: 10 years
3 secondary outcomes
Rate of the secondary surgical procedures required for correction of complications
Time frame: 10 years
Rate and frequency of local complications
Time frame: 10 years
Patient satisfaction
Time frame: 10 years
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 6 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Augmentation
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
Recruiting
Improved Breast Enlargement Using the Subject's Own Fat Tissue
Breast Augmentation
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Augmentation and Breast Reconstruction, run by GCA (Eurosilicone) at 2 sites in 2 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 5 inclusion and 12 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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 GCA Clinical affairs department (+33 783326098, luna10PMCF@gcaesthetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and rate of implant rupture (time frame: 10 years). 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 6 Jul 2026.