A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants (NCT07679594) | Clinical Trial Compass
RecruitingNot Applicable
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
France, Spain650 participantsStarted 2026-03-30
Plain-language 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 revision of breast augmentation or breast reconstruction.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and rate of implant rupture
Timeframe: 10 years
2
Frequency and rate of capsular contracture Baker III-IV
. 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.
. 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.