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

Recruiting Observational Study
Breast Augmentation Breast Reconstruction Breast Revision-Augmentation Breast Reconstruction With Silicone Implants Breast Reconstruction, Revision Breast Reconstruction Breast Augmentation and Breast Reconstruction
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 65
Sex
Female
Study type
Observational
Participants needed
650 (estimated)
Sponsor
GCA (Eurosilicone) · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * The target population includes subjects undergoing augmentation or reconstructive breast implant surgery in which the Eurosilicone Luna mammary implant is recommended. Inclusion criteria are: 1. Genetic female subjects aged between 18 and 65 years old. 2. Subjects who underw…
Contacts

GCA Clinical affairs department

+33 783326098

luna10PMCF@gcaesthetics.com

CONTACT