RecruitingNCT07679594

A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants

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.

Sponsor

GCA (Eurosilicone)

Enrollment

650 participants

Start Date

Mar 30, 2026

Study Type

OBSERVATIONAL

Conditions

Breast Reconstruction Breast Augmentation Breast Reconstruction With Silicone Implants Breast Revision-Augmentation Breast Reconstruction, Revision Breast Reconstruction Breast Augmentation and Breast Reconstruction

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Breast augmentation surgery and a procedure called Breast reconstruction surgery for people with breast augmentation, breast augmentation and breast reconstruction, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBreast augmentation surgery

The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.

PROCEDUREBreast reconstruction surgery

The procedure is carried out at the surgeon's discretion. This includes the incision location, the implant placement, the intraoperative applications.

Locations(2)

Dr Guillaume Lasserre

Villefranche-sur-Saône, France

DScultp Clinic

Barcelona, Spain

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NCT07679594

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