Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-25.
Trial Details
NCT Number NCT07679594
Lead Sponsor GCA (Eurosilicone)
Conditions Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants, Breast Reconstruction, Revision Breast Reconstruction, Breast Augmentation and Breast Reconstruction
Enrollment 650 participants
Start Date 2026-03-30
Primary Completion 2038-12-31 (estimated)
Study Completion 2038-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06