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

NCT07679594 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Breast augmentation surgery

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

PROCEDURE

Breast reconstruction surgery

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

Sponsors & Collaborators

  • GCA (Eurosilicone)

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2038-12-31
Completion
2038-12-31

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679594 on ClinicalTrials.gov